A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy

ID: NCT00708201
Status: Completed
Phase: Phase 4
Start Date: March 01, 2009
First Submitted: June 27, 2008
Last Updated: January 06, 2016
Results: Available
Success Rate: 95%
Sponsors & Collaborators: Cubist Pharmaceuticals LLC
Location: United States
Conditions: Postoperative Ileus
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Study Description

Brief Summary

This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are:

- to evaluate the effect of alvimopan on hospital length of stay

- to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities

- to evaluate the overall and cardiovascular safety of alvimopan

Detailed Description

Condition or disease Intervention/treatment Phase

Postoperative Ileus

Drug: Alvimopan
Other Names
ADL2698 Entereg
Drug: Placebo
Other Names
Phase 4

Tracking Information

First Submitted DateJune 27, 2008
Last Update Posted DateJanuary 06, 2016
Start DateMarch 01, 2009
Actual Completion DateJanuary 01, 2012
Primary Completion DateJanuary 01, 2012
Results First Submitted DateSeptember 10, 2013
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model [Time Frame: From day of surgery (Day 0) up to 10 days in hospital]

    Time to achieve recovery of gastrointestinal (GI) function as measured by a composite endpoint of both upper GI recovery (toleration of solid food) and lower GI recovery (first bowel movement [BM]) using KM Estimates and Cox PH Model. This endpoint was referred to as GI2. GI2 was calculated as GI2 = maximum (max) (solids, BM). The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration]. Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)

Original Primary Outcome Measures

  • Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model

    Time to achieve recovery of gastrointestinal (GI) function as measured by a composite endpoint of both upper GI recovery (toleration of solid food) and lower GI recovery (first bowel movement [BM]) using KM Estimates and Cox PH Model. This endpoint was referred to as GI2. GI2 was calculated as GI2 = maximum (max) (solids, BM). The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration]. Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)

Current Secondary Outcome Measures

  • Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model [Time Frame: Day of surgery (Day 0) up to 10 days in hospital]

    The endpoint of "time to ready for discharge" was based solely on the recovery of GI function as determined by the surgeon. The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration]. Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)

  • Mean Time to Discharge Order Written (DOW) Using KM Estimates [Time Frame: Day of surgery (Day 0) up to 10 days in hospital]

    The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration]. Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)

  • Postoperative Length of Stay (LOS) [Time Frame: Day of surgery (Day 0) to the day of hospital DOW]

    The postoperative LOS was determined by the difference between the date of hospital DOW and the date of surgery; that is, the postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery).

  • Percentage of Participants Considered Postoperative LOS Responders [Time Frame: Day of surgery (Day 0) up to 7 days after surgery]

    A participant was considered a postoperative LOS responder if the postoperative LOS was less than or equal to 7 days. The postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery). Participants with missing data were considered nonresponders.

  • Percentage of Participants With Postoperative Morbidity (POM) [Time Frame: During hospitalization or within 7 days after discharge]

    POM was defined as the need for postoperative nasogastric (NG) tube insertion, hospital stay prolonged because of postoperative ileus (POI) (as determined by the investigator), or readmission (readmiss) to the hospital (hosp) for POI within 7 days (d) after discharge.

  • Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points [Time Frame: Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7]

    Time to achieve recovery of GI function was measured by a composite endpoint of time to first BM and time to tolerate first solid food (solids). This endpoint was referred to as GI2, and GI2 was calculated as follows: GI2 = max (solids, BM). GI2 responders were defined as those participants who met all the following criteria: achieved GI2 by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. Postsurgery Days (PSD) were measured in 24 hour increments after surgery.

  • Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points [Time Frame: Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7]

    DOW responders were defined as those participants who met all the following criteria: achieved DOW by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. PSD were measured in 24 hour increments after surgery.

  • Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events [Time Frame: Baseline to 30 days post discharge]

    CV events of interest included congestive heart failure, CV death, cerebrovascular accident, myocardial infarction, serious arrhythmia, and unstable angina. CV events were adjudicated by a blinded external committee.

Original Secondary Outcome Measures

  • Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events

    CV events of interest included congestive heart failure, CV death, cerebrovascular accident, myocardial infarction, serious arrhythmia, and unstable angina. CV events were adjudicated by a blinded external committee.

  • Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points

    DOW responders were defined as those participants who met all the following criteria: achieved DOW by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. PSD were measured in 24 hour increments after surgery.

  • Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points

    Time to achieve recovery of GI function was measured by a composite endpoint of time to first BM and time to tolerate first solid food (solids). This endpoint was referred to as GI2, and GI2 was calculated as follows: GI2 = max (solids, BM). GI2 responders were defined as those participants who met all the following criteria: achieved GI2 by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. Postsurgery Days (PSD) were measured in 24 hour increments after surgery.

  • Percentage of Participants With Postoperative Morbidity (POM)

    POM was defined as the need for postoperative nasogastric (NG) tube insertion, hospital stay prolonged because of postoperative ileus (POI) (as determined by the investigator), or readmission (readmiss) to the hospital (hosp) for POI within 7 days (d) after discharge.

  • Percentage of Participants Considered Postoperative LOS Responders

    A participant was considered a postoperative LOS responder if the postoperative LOS was less than or equal to 7 days. The postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery). Participants with missing data were considered nonresponders.

  • Postoperative Length of Stay (LOS)

    The postoperative LOS was determined by the difference between the date of hospital DOW and the date of surgery; that is, the postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery).

  • Mean Time to Discharge Order Written (DOW) Using KM Estimates

    The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration]. Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)

  • Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model

    The endpoint of “time to ready for discharge” was based solely on the recovery of GI function as determined by the surgeon. The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration]. Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)

Study Design

Brief TitleA Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy
Official TitleA Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.
Brief Summary

This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are:

- to evaluate the effect of alvimopan on hospital length of stay

- to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities

- to evaluate the overall and cardiovascular safety of alvimopan

Detailed Description

Study TypeInterventional
Study PhasePhase 4
Estimated Enrollment
280
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Postoperative Ileus
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Alvimopan

Other Names
ADL2698
Entereg
Drug: Placebo

Other Names
Study Groups/Cohorts
Alvimopan
12 milligrams (mg) Alvimopan, 12mg, capsule. Administered orally. One 30 minutes to 5 hours before the scheduled start of surgery on Day 0, and twice daily beginning on Postoperative Day 1 (POD 1) until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment

Placebo
300 mg polyethylene glycol in a capsule Administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.

Study Arms
Experimental Alvimopan
12 milligrams (mg) Alvimopan, 12mg, capsule. Administered orally. One 30 minutes to 5 hours before the scheduled start of surgery on Day 0, and twice daily beginning on Postoperative Day 1 (POD 1) until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment
Drug : Alvimopan

Placebo Comparator Placebo
300 mg polyethylene glycol in a capsule Administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Drug : Placebo

Arm Intervention/Treatment
Experimental Alvimopan
12 milligrams (mg) Alvimopan, 12mg, capsule. Administered orally. One 30 minutes to 5 hours before the scheduled start of surgery on Day 0, and twice daily beginning on Postoperative Day 1 (POD 1) until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment
Drug : Alvimopan
Placebo Comparator Placebo
300 mg polyethylene glycol in a capsule Administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Drug : Placebo

Recruitment Information

Recruitment Status:Completed
Enrollment280
Completion DateJanuary 01, 2012
Eligibility Criteria: Inclusion Criteria:
- are either Male or Female at least 18 years of age
- are scheduled for radical cystectomy
- are scheduled to receive postoperative pain management with intravenous participant-controlled opioid analgesics

Exclusion Criteria:
- are scheduled for a partial cystectomy
- have taken more than 3 doses of opioids (oral or parenteral) within 7 days before the day of surgery
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00708201
Other Study ID Numbers
3753-002
14CL403
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Not Available
Investigators
Study Director
Lee Techner, DPM
Cubist Pharmaceuticals LLC

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Not Available

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not Available

Reporting Groups

TitleDescription
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.

Participant Flow: Overall

PlaceboAlvimopan 12 mg
130137
Started137143
Completed130137
Not Completed76
Adverse Event44
Lost to Follow-up20
Protocol Violation01
Withdrawal by Subject11

Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants

Reporting Groups

TitleDescription
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
Total
Total of all reporting groups

Baseline Measures

PlaceboAlvimopan 12 mgTotal
Overall Participants Analyzed
Units: Participants
Participants Analyzed
137143280
137143280
Age
Units: Years - Mean (Standard Deviation)
Participants Analyzed
137143280
63.9 (9.84)66.3 (10.93)65.1 (10.39)
Gender
Units: participants - Number
Participants Analyzed
137143280
Female273057
Male110113223
Ethnicity (NIH/OMB)
Units: participants - Number
Participants Analyzed
137143280
Hispanic or Latino314
Not Hispanic or Latino134142276
Unknown or Not Reported000
Race (NIH/OMB)
Units: participants - Number
Participants Analyzed
137143280
American Indian or Alaska Native000
Asian000
Black or African American6410
More than one race000
Native Hawaiian or Other Pacific Islander011
Unknown or Not Reported000
White131138269

Outcome Measures

1. Primary: Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model

Measure Type
Primary
Measure Title
Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model
Measure Description
Time to achieve recovery of gastrointestinal (GI) function as measured by a composite endpoint of both upper GI recovery (toleration of solid food) and lower GI recovery (first bowel movement [BM]) using KM Estimates and Cox PH Model. This endpoint was referred to as GI2. GI2 was calculated as GI2 = maximum (max) (solids, BM). The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration]. Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)
Time Frame
From day of surgery (Day 0) up to 10 days in hospital

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data. 39 participants in the Placebo group and 17 participants in the Alvimopan group were censored.

Reporting Groups

TitleDescription
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.

Outcome Measures

PlaceboAlvimopan 12 mg
Participants Analyzed
Units: Participants
134143
Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model
Units: Hours - Mean (Standard Error)
164.2 (5.56)132.7 (4.30)

Statistical Analysis

Groups
All Groups
Statistical Test Type
Superiority or Other
Statistical Method
Wald’s Chi-Square
P Value
<0.00010
Hazard Ratio (HR)
1.77300
95% Confidence Interval
1.35900 to 2.31100
  1. Additional details about the analysis, such as null hypothesis and power calculation
    Not Available
  2. Details of power calculation, definition of non-inferiority margin, and other key parameters
    Not Available
  3. Other relevant method information, such as adjustments or degrees of freedom
    Not Available
  4. Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance
    Not Available
  5. Other relevant estimation information
    Not Available

2. Secondary: Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model

Measure Type
Secondary
Measure Title
Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model
Measure Description
The endpoint of “time to ready for discharge” was based solely on the recovery of GI function as determined by the surgeon. The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration]. Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)
Time Frame
Day of surgery (Day 0) up to 10 days in hospital

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable ready to discharge data. 21 participants in the Placebo group and 12 participants in the Alvimopan group were censored.

Reporting Groups

TitleDescription
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.

Outcome Measures

PlaceboAlvimopan 12 mg
Participants Analyzed
Units: Participants
134143
Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model
Units: Hours - Mean (Standard Error)
154.7 (5.28)130.0 (4.15)

Statistical Analysis

Groups
All Groups
Statistical Test Type
Superiority or Other
Statistical Method
Log Rank
P Value
<0.00100
Mean Difference (Final Values)
-24.70000
95% Confidence Interval
-37.80000 to -11.50000
  1. Additional details about the analysis, such as null hypothesis and power calculation
    Not Available
  2. Details of power calculation, definition of non-inferiority margin, and other key parameters
    Not Available
  3. Other relevant method information, such as adjustments or degrees of freedom
    Not Available
  4. Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance
    Not Available
  5. Other relevant estimation information
    Not Available

3. Secondary: Mean Time to Discharge Order Written (DOW) Using KM Estimates

Measure Type
Secondary
Measure Title
Mean Time to Discharge Order Written (DOW) Using KM Estimates
Measure Description
The KM estimate reported below is biased because of the censoring of the last observation. Censoring Rules for Study Participants who: Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration]. Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)
Time Frame
Day of surgery (Day 0) up to 10 days in hospital

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to DOW data. 36 participants in the Placebo group and 15 participants in the Alvimopan group were censored.

Reporting Groups

TitleDescription
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.

Outcome Measures

PlaceboAlvimopan 12 mg
Participants Analyzed
Units: Participants
134143
Mean Time to Discharge Order Written (DOW) Using KM Estimates
Units: Hours - Mean (Standard Error)
188.4 (5.11)166.0 (3.89)

Statistical Analysis

Groups
All Groups
Statistical Test Type
Superiority or Other
Statistical Method
Log Rank
P Value
<0.00100
Mean Difference (Final Values)
-22.40000
95% Confidence Interval
-35.00000 to -9.90000
  1. Additional details about the analysis, such as null hypothesis and power calculation
    Not Available
  2. Details of power calculation, definition of non-inferiority margin, and other key parameters
    Not Available
  3. Other relevant method information, such as adjustments or degrees of freedom
    Not Available
  4. Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance
    Not Available
  5. Other relevant estimation information
    Not Available

4. Secondary: Postoperative Length of Stay (LOS)

Measure Type
Secondary
Measure Title
Postoperative Length of Stay (LOS)
Measure Description
The postoperative LOS was determined by the difference between the date of hospital DOW and the date of surgery; that is, the postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery).
Time Frame
Day of surgery (Day 0) to the day of hospital DOW

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable postoperative LOS data.

Reporting Groups

TitleDescription
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.

Outcome Measures

PlaceboAlvimopan 12 mg
Participants Analyzed
Units: Participants
134143
Postoperative Length of Stay (LOS)
Units: Days - Mean (Standard Deviation)
10.07 (8.23)7.44 (3.05)

Statistical Analysis

Groups
All Groups
Statistical Test Type
Superiority or Other
Statistical Method
Wilcoxon (Mann-Whitney)
P Value
<0.01000
Not Available
Not Available
to
  1. Additional details about the analysis, such as null hypothesis and power calculation
    Not Available
  2. Details of power calculation, definition of non-inferiority margin, and other key parameters
    Not Available
  3. Other relevant method information, such as adjustments or degrees of freedom
    Not Available
  4. Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance
    Not Available
  5. Other relevant estimation information
    Not Available

5. Secondary: Percentage of Participants Considered Postoperative LOS Responders

Measure Type
Secondary
Measure Title
Percentage of Participants Considered Postoperative LOS Responders
Measure Description
A participant was considered a postoperative LOS responder if the postoperative LOS was less than or equal to 7 days. The postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery). Participants with missing data were considered nonresponders.
Time Frame
Day of surgery (Day 0) up to 7 days after surgery

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable postoperative LOS data.

Reporting Groups

TitleDescription
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.

Outcome Measures

PlaceboAlvimopan 12 mg
Participants Analyzed
Units: Participants
134143
Percentage of Participants Considered Postoperative LOS Responders
Units: percentage of participants - Number
48.567.1

Statistical Analysis

Groups
All Groups
Statistical Test Type
Superiority or Other
Statistical Method
Fisher Exact
P Value
<0.01000
Relative Risk
1.38000
95% Confidence Interval
1.12000 to 1.71000
  1. Additional details about the analysis, such as null hypothesis and power calculation
    Not Available
  2. Details of power calculation, definition of non-inferiority margin, and other key parameters
    Not Available
  3. Other relevant method information, such as adjustments or degrees of freedom
    Not Available
  4. Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance
    Not Available
  5. Other relevant estimation information
    This is the relative risk for being a responder (alvimopan/placebo).

6. Secondary: Percentage of Participants With Postoperative Morbidity (POM)

Measure Type
Secondary
Measure Title
Percentage of Participants With Postoperative Morbidity (POM)
Measure Description
POM was defined as the need for postoperative nasogastric (NG) tube insertion, hospital stay prolonged because of postoperative ileus (POI) (as determined by the investigator), or readmission (readmiss) to the hospital (hosp) for POI within 7 days (d) after discharge.
Time Frame
During hospitalization or within 7 days after discharge

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable POM data.

Reporting Groups

TitleDescription
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.

Outcome Measures

PlaceboAlvimopan 12 mg
Participants Analyzed
Units: Participants
134143
Percentage of Participants With Postoperative Morbidity (POM)
Units: percentage of participants - Number
Overall POM (n=134, 143)29.18.4
POI rslt in readmiss to hosp in ≤7days(n=134,143)0.80.7
Postoperative NG tube insertion (n=134, 143)24.67.7
Prolonged hospital stay due to POI (n=133, 143)21.83.5

Statistical Analysis

Groups
All Groups
Statistical Test Type
Superiority or Other
Statistical Method
Fisher Exact
P Value
<0.00100
Percent difference
-20.71000
to
  1. Additional details about the analysis, such as null hypothesis and power calculation
    Not Available
  2. Details of power calculation, definition of non-inferiority margin, and other key parameters
    Not Available
  3. Other relevant method information, such as adjustments or degrees of freedom
    Not Available
  4. Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance
    Not Available
  5. Other relevant estimation information
    Percent difference = alvimopan − placebo

7. Secondary: Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points

Measure Type
Secondary
Measure Title
Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points
Measure Description
Time to achieve recovery of GI function was measured by a composite endpoint of time to first BM and time to tolerate first solid food (solids). This endpoint was referred to as GI2, and GI2 was calculated as follows: GI2 = max (solids, BM). GI2 responders were defined as those participants who met all the following criteria: achieved GI2 by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. Postsurgery Days (PSD) were measured in 24 hour increments after surgery.
Time Frame
Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data.

Reporting Groups

TitleDescription
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.

Outcome Measures

PlaceboAlvimopan 12 mg
Participants Analyzed
Units: Participants
134143
Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points
Units: percentage of participants - Number
PSD 39.725.2
PSD 427.653.8
PSD 542.575.5
PSD 653.079.7
PSD 757.584.6

Statistical Analysis

Groups
All Groups
Statistical Test Type
Superiority or Other
Statistical Method
Fisher Exact
P Value
<0.00010
Percent difference
27.05000
to
  1. Additional details about the analysis, such as null hypothesis and power calculation
    Not Available
  2. Details of power calculation, definition of non-inferiority margin, and other key parameters
    Not Available
  3. Other relevant method information, such as adjustments or degrees of freedom
    Not Available
  4. Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance
    Not Available
  5. Other relevant estimation information
    Percent difference = alvimopan − placebo

8. Secondary: Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points

Measure Type
Secondary
Measure Title
Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points
Measure Description
DOW responders were defined as those participants who met all the following criteria: achieved DOW by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. PSD were measured in 24 hour increments after surgery.
Time Frame
Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data.

Reporting Groups

TitleDescription
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.

Outcome Measures

PlaceboAlvimopan 12 mg
Participants Analyzed
Units: Participants
134143
Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points
Units: percentage of participants - Number
PSD 30.72.8
PSD 417.914
PSD 532.139.9
PSD 647.862.2
PSD 755.280.4

Statistical Analysis

Groups
All Groups
Statistical Test Type
Superiority or Other
Statistical Method
Fisher Exact
P Value
<0.00010
Percent difference
25.20000
to
  1. Additional details about the analysis, such as null hypothesis and power calculation
    Not Available
  2. Details of power calculation, definition of non-inferiority margin, and other key parameters
    Not Available
  3. Other relevant method information, such as adjustments or degrees of freedom
    Not Available
  4. Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance
    Not Available
  5. Other relevant estimation information
    Percent difference = alvimopan − placebo

9. Secondary: Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events

Measure Type
Secondary
Measure Title
Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events
Measure Description
CV events of interest included congestive heart failure, CV death, cerebrovascular accident, myocardial infarction, serious arrhythmia, and unstable angina. CV events were adjudicated by a blinded external committee.
Time Frame
Baseline to 30 days post discharge

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study medication.

Reporting Groups

TitleDescription
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.

Outcome Measures

PlaceboAlvimopan 12 mg
Participants Analyzed
Units: Participants
137143
Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events
Units: percentage of participants - Number
Cerebrovascular accident0.70.7
Congestive heart failure2.90.0
CV death2.90.7
Myocardial infarction7.32.8
Overall CV events of interest15.38.4
Serious arrhythmia5.15.6
Unstable angina0.70.7

Statistical Analysis

Groups
All Groups
Statistical Test Type
Superiority or Other
Statistical Method
Fisher Exact
P Value
0.09460
Percent difference
-6.94000
95% Confidence Interval
-14.50000 to 0.62000
  1. Additional details about the analysis, such as null hypothesis and power calculation
    Not Available
  2. Details of power calculation, definition of non-inferiority margin, and other key parameters
    Not Available
  3. Other relevant method information, such as adjustments or degrees of freedom
    Not Available
  4. Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance
    Not Available
  5. Other relevant estimation information
    Percent difference = alvimopan − placebo.

Serious Adverse Events

Time Frame
Not Available
Additional Description
Not Available
Frequency Threshold0% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.

Serious Adverse Events

PlaceboAlvimopan 12 mg
Total, serious adverse events
No. of participants affected / at risk67/137 (0.00%)51/143 (0.00%)
Leukocytosis
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Acute Coronary Syndrome
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Acute Myocardial Infarction
No. of participants affected / at risk2/137 (0.00%)0/143 (0.00%)
Angina Pectoris
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Atrial Fibrillation
No. of participants affected / at risk2/137 (0.00%)0/143 (0.00%)
Cardiac Arrest
No. of participants affected / at risk2/137 (0.00%)0/143 (0.00%)
Cardio-Respiratory Arrest
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Myocardial Infarction
No. of participants affected / at risk2/137 (0.00%)2/143 (0.00%)
Tachycardia
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Ventricular Tachycardia
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Gastrointestinal Angiodysplasia Haemorrhagic
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Abdominal Distension
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Abdominal Pain
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Ascites
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Constipation
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Diarrhoea
No. of participants affected / at risk2/137 (0.00%)2/143 (0.00%)
Enterocutaneous Fistula
No. of participants affected / at risk1/137 (0.00%)1/143 (0.00%)
Enterovesical Fistula
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Intestinal Perforation
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Pancreatitis
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Small Intestinal Obstruction
No. of participants affected / at risk7/137 (0.00%)1/143 (0.00%)
Asthenia
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Device Malfunction
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Non-Cardiac Chest Pain
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Pyrexia
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Sudden Death
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Hepatic Cirrhosis
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Hepatitis Chronic Active
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Abdominal Abscess
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Abdominal Infection
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Bacteraemia
No. of participants affected / at risk1/137 (0.00%)2/143 (0.00%)
Clostridial Infection
No. of participants affected / at risk2/137 (0.00%)1/143 (0.00%)
Clostridium Difficile Colitis
No. of participants affected / at risk1/137 (0.00%)1/143 (0.00%)
Fungal Oesophagitis
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Fungal Sepsis
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Incision Site Infection
No. of participants affected / at risk1/137 (0.00%)1/143 (0.00%)
Pelvic Abscess
No. of participants affected / at risk2/137 (0.00%)3/143 (0.00%)
Pneumonia
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Postoperative Wound Infection
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Pyelonephritis
No. of participants affected / at risk1/137 (0.00%)4/143 (0.00%)
Pyelonephritis Acute
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Retroperitoneal Abscess
No. of participants affected / at risk0/137 (0.00%)2/143 (0.00%)
Sepsis
No. of participants affected / at risk3/137 (0.00%)1/143 (0.00%)
Septic Shock
No. of participants affected / at risk0/137 (0.00%)2/143 (0.00%)
Urinary Tract Infection
No. of participants affected / at risk2/137 (0.00%)5/143 (0.00%)
Urinary Tract Infection Enterococcal
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Urinary Tract Infection Staphylococcal
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Urosepsis
No. of participants affected / at risk1/137 (0.00%)2/143 (0.00%)
Abdominal Wound Dehiscence
No. of participants affected / at risk2/137 (0.00%)1/143 (0.00%)
Fall
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Gastrointestinal Anastomotic Leak
No. of participants affected / at risk1/137 (0.00%)1/143 (0.00%)
Gun Shot Wound
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Incisional Hernia
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Post Procedural Haemorrhage
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Postoperative Fever
No. of participants affected / at risk2/137 (0.00%)0/143 (0.00%)
Postoperative Ileus
No. of participants affected / at risk28/137 (0.00%)7/143 (0.00%)
Postoperative Wound Complication
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Procedural Hypotension
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Toxicity To Various Agents
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Urinary Anastomotic Leak
No. of participants affected / at risk2/137 (0.00%)0/143 (0.00%)
Urinary Retention Postoperative
No. of participants affected / at risk1/137 (0.00%)2/143 (0.00%)
Wound Dehiscence
No. of participants affected / at risk2/137 (0.00%)2/143 (0.00%)
Clostridium Test Positive
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Culture Positive
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Staphylococcus Test Positive
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Dehydration
No. of participants affected / at risk7/137 (0.00%)3/143 (0.00%)
Failure To Thrive
No. of participants affected / at risk2/137 (0.00%)0/143 (0.00%)
Hypercalcaemia
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Hyperkalaemia
No. of participants affected / at risk1/137 (0.00%)1/143 (0.00%)
Hyponatraemia
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Hypovolaemia
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Malnutrition
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Arthralgia
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Groin Pain
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Rhabdomyolysis
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Throat Cancer
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Cerebral Infarction
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Cerebrovascular Accident
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Dizziness
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Neuropathy Peripheral
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Presyncope
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Completed Suicide
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Delirium
No. of participants affected / at risk1/137 (0.00%)1/143 (0.00%)
Mental Status Changes
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Haematuria
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Renal Failure
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Renal Failure Acute
No. of participants affected / at risk3/137 (0.00%)3/143 (0.00%)
Urinoma
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Pelvic Fluid Collection
No. of participants affected / at risk2/137 (0.00%)2/143 (0.00%)
Acute Respiratory Failure
No. of participants affected / at risk0/137 (0.00%)2/143 (0.00%)
Pulmonary Embolism
No. of participants affected / at risk5/137 (0.00%)1/143 (0.00%)
Respiratory Failure
No. of participants affected / at risk0/137 (0.00%)1/143 (0.00%)
Abdominal Cavity Drainage
No. of participants affected / at risk1/137 (0.00%)0/143 (0.00%)
Deep Vein Thrombosis
No. of participants affected / at risk5/137 (0.00%)1/143 (0.00%)
Hypotension
No. of participants affected / at risk1/137 (0.00%)2/143 (0.00%)

Other Adverse Events

Time Frame
Not Available
Additional Description
Not Available
Frequency Threshold5% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
Placebo
A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Alvimopan 12 mg
A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.

Other Adverse Events

PlaceboAlvimopan 12 mg
Total, other adverse events
No. of participants affected / at risk128/137 (0.00%)127/143 (0.00%)
Anaemia
No. of participants affected / at risk34/137 (0.00%)27/143 (0.00%)
Leukocytosis
No. of participants affected / at risk9/137 (0.00%)2/143 (0.00%)
Tachycardia
No. of participants affected / at risk16/137 (0.00%)13/143 (0.00%)
Sinus Tachycardia
No. of participants affected / at risk8/137 (0.00%)3/143 (0.00%)
Nausea
No. of participants affected / at risk32/137 (0.00%)15/143 (0.00%)
Constipation
No. of participants affected / at risk19/137 (0.00%)21/143 (0.00%)
Diarrhoea
No. of participants affected / at risk17/137 (0.00%)13/143 (0.00%)
Flatulence
No. of participants affected / at risk14/137 (0.00%)7/143 (0.00%)
Vomiting
No. of participants affected / at risk11/137 (0.00%)4/143 (0.00%)
Abdominal Pain
No. of participants affected / at risk9/137 (0.00%)6/143 (0.00%)
Dyspepsia
No. of participants affected / at risk9/137 (0.00%)6/143 (0.00%)
Pyrexia
No. of participants affected / at risk20/137 (0.00%)18/143 (0.00%)
Oedema Peripheral
No. of participants affected / at risk17/137 (0.00%)9/143 (0.00%)
Urinary Tract Infection
No. of participants affected / at risk18/137 (0.00%)11/143 (0.00%)
Anaemia Postoperative
No. of participants affected / at risk11/137 (0.00%)9/143 (0.00%)
Postoperative Ileus
No. of participants affected / at risk9/137 (0.00%)4/143 (0.00%)
Haemoglobin Decreased
No. of participants affected / at risk8/137 (0.00%)4/143 (0.00%)
Blood Creatinine Increased
No. of participants affected / at risk7/137 (0.00%)4/143 (0.00%)
Troponin Increased
No. of participants affected / at risk7/137 (0.00%)5/143 (0.00%)
Urine Output Decreased
No. of participants affected / at risk7/137 (0.00%)6/143 (0.00%)
Hypokalaemia
No. of participants affected / at risk40/137 (0.00%)27/143 (0.00%)
Hypocalcaemia
No. of participants affected / at risk24/137 (0.00%)21/143 (0.00%)
Hypomagnesaemia
No. of participants affected / at risk17/137 (0.00%)19/143 (0.00%)
Hyperglycaemia
No. of participants affected / at risk14/137 (0.00%)15/143 (0.00%)
Hypophosphataemia
No. of participants affected / at risk12/137 (0.00%)12/143 (0.00%)
Hyponatraemia
No. of participants affected / at risk8/137 (0.00%)6/143 (0.00%)
Malnutrition
No. of participants affected / at risk8/137 (0.00%)3/143 (0.00%)
Hyperkalaemia
No. of participants affected / at risk7/137 (0.00%)5/143 (0.00%)
Back Pain
No. of participants affected / at risk11/137 (0.00%)1/143 (0.00%)
Insomnia
No. of participants affected / at risk20/137 (0.00%)19/143 (0.00%)
Anxiety
No. of participants affected / at risk9/137 (0.00%)12/143 (0.00%)
Renal Failure Acute
No. of participants affected / at risk8/137 (0.00%)6/143 (0.00%)
Hiccups
No. of participants affected / at risk7/137 (0.00%)5/143 (0.00%)
Pruritus
No. of participants affected / at risk17/137 (0.00%)10/143 (0.00%)
Hypotension
No. of participants affected / at risk13/137 (0.00%)13/143 (0.00%)
Hypertension
No. of participants affected / at risk10/137 (0.00%)13/143 (0.00%)

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleOrganizationPhoneEmail
Vice President, Clinical Research
Cubist Pharmaceuticals
(781) 860-8660