Clinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With Opioid

ID: NCT00331045
Status: Terminated
Phase: Phase 2
Start Date: April 01, 2006
First Submitted: May 26, 2006
Last Updated: September 01, 2015
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC, GlaxoSmithKline
Location: N/A
Conditions: Cancer, Constipation
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Study Description

Brief Summary

This study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day (0.25mg, OD), 0.5mg/day (0.25mg, BID) or 1mg/day (0.5mg, BID) or placebo for 3 weeks in patients who receive opioids for the management of cancer pain and develop constipation, by giving overall consideration to the efficacy and safety data in each treatment group. Also, efficacy and safety data of alvimopan in the recommended dose group will be compared with those of placebo and to confirm alvimopan's safety and efficacy.

Detailed Description

Condition or disease Intervention/treatment Phase

Cancer

Constipation

Drug: alvimopan
Other Names
SB767905
Drug: Placebo
Other Names
Drug: Alvimopan 0.5 mg/day
Other Names
Drug: Alvimopan 1 mg/day
Other Names
Phase 2

Tracking Information

First Submitted DateMay 26, 2006
Last Update Posted DateSeptember 01, 2015
Start DateApril 01, 2006
Actual Completion DateDecember 01, 2006
Primary Completion DateOctober 01, 2006
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Change from baseline during the 1-week Pre-Treatment Period in average weekly bowel movement with no rescue laxative use in the previous 24 hours Frequency during the 3-week Treatment Period

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Proportion of responders for OBD global improvement Changes in weekly subjective bowel movement symptoms Changes in weekly constipation symptoms questionnaire

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleClinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With Opioid
Official TitleClinical Evaluation of Alvimopan (SB767905) on Constipation and Related Symptoms Associated With Opioid -A Placebo-controlled Double-blind Study in Cancer Patients-
Brief Summary

This study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day (0.25mg, OD), 0.5mg/day (0.25mg, BID) or 1mg/day (0.5mg, BID) or placebo for 3 weeks in patients who receive opioids for the management of cancer pain and develop constipation, by giving overall consideration to the efficacy and safety data in each treatment group. Also, efficacy and safety data of alvimopan in the recommended dose group will be compared with those of placebo and to confirm alvimopan's safety and efficacy.

Detailed Description

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
21
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Cancer
Constipation
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: alvimopan

0.25 mg/day

Other Names
SB767905
Drug: Placebo

Other Names
Drug: Alvimopan 0.5 mg/day

Other Names
Drug: Alvimopan 1 mg/day

Other Names
Study Groups/Cohorts
Placebo

Alvimopan 0.25 mg/yday

Alviompan 0.5 mg/day

Alvimopan 1 mg/day

Study Arms
Experimental Alvimopan 0.25 mg/yday
Drug : alvimopan
0.25 mg/day

Experimental Alvimopan 1 mg/day
Drug : Alvimopan 1 mg/day

Experimental Alviompan 0.5 mg/day
Drug : Alvimopan 0.5 mg/day

Placebo Comparator Placebo
Drug : Placebo

Arm Intervention/Treatment
Experimental Alvimopan 0.25 mg/yday
Drug : alvimopan
Experimental Alvimopan 1 mg/day
Drug : Alvimopan 1 mg/day
Experimental Alviompan 0.5 mg/day
Drug : Alvimopan 0.5 mg/day
Placebo Comparator Placebo
Drug : Placebo

Recruitment Information

Recruitment Status:Terminated
Enrollment21
Completion DateDecember 01, 2006
Eligibility Criteria: Inclusion criteria:
- Have cancer.
- Taking opioid therapy for continued intractable pain.
- Experiencing less bowel movement frequency compared to that before the opioid treatment.
- Must meet the protocol-definition of opioid-induced constipation.
Exclusion criteria:
- Gastrointestinal or pelvic disorders known to affect gastrointestinal functions or induce bowel transit disorder and ileus.
- Subjects, who in the investigator's opinion, have gastrointestinal dysfunction predominantly due to causes other than the use of opioids.
GenderAll
Age20 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Japan

Administrative Information

NCT Number:NCT00331045
Other Study ID Numbers
ABD102965
Has Data Monitoring CommitteeNo
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
GlaxoSmithKline
Investigators
Study Director
GSK Clinical Trials, MD
GlaxoSmithKline