Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

ID: NCT00101998
Status: Completed
Phase: Phase 2
Start Date: October 01, 2003
First Submitted: January 18, 2005
Last Updated: August 29, 2017
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC, GlaxoSmithKline
Location: Argentina, Australia, Canada, Czechia, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Korea, Republic of, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Russian Federation, South Africa, Spain, Taiwan, Thailand, United Kingdom, United States
Conditions: Constipation, Bowel Dysfunction
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Study Description

Brief Summary

A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.

Detailed Description

Condition or disease Intervention/treatment Phase

Bowel Dysfunction

Constipation

Drug: alvimopan
Other Names
Drug: placebo
Other Names
Phase 2

Tracking Information

First Submitted DateJanuary 18, 2005
Last Update Posted DateAugust 29, 2017
Actual Start DateOctober 01, 2003
Actual Completion DateMay 01, 2006
Actual Primary Completion DateMay 01, 2006
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Change in weekly SCBM frequency. A SCBM is a spontaneous and complete bowel movement, which means a bowel movement that occurs with no laxative use in the prior 24 hours and leaves the subject with the feeling of complete evacuation of the rectum.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Additional measures of Bowel movement (BM) frequency and symptoms, safety profile of the treatment regimens and any changes in pain intensity or opioid use.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleStudy Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication
Official TitleA Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
Brief Summary

A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.

Detailed Description

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
233
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Treatment
Conditions
Bowel Dysfunction
Constipation
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: alvimopan

Other Names
Drug: placebo

Other Names
Study Groups/Cohorts
Alvimopan 0.5 mg Twice Daily (BID)
0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks.

Alvimopan 1 mg Once Daily (QD)
0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind. A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment.

Alvimopan 1 mg Twice Daily (BID)
0.5 mg of alvimopan was administered orally BID for 3 days, then 1 mg of alvimopan BID for the remaining 3 weeks.

Placebo
Placebo was administered orally BID for 3 weeks.

Study Arms
Experimental Alvimopan 0.5 mg Twice Daily (BID)
0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks.
Drug : alvimopan

Experimental Alvimopan 1 mg Once Daily (QD)
0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind. A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment.
Drug : alvimopan

Experimental Alvimopan 1 mg Once Daily (QD)
0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind. A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment.
Drug : placebo

Experimental Alvimopan 1 mg Twice Daily (BID)
0.5 mg of alvimopan was administered orally BID for 3 days, then 1 mg of alvimopan BID for the remaining 3 weeks.
Drug : alvimopan

Placebo Comparator Placebo
Placebo was administered orally BID for 3 weeks.
Drug : placebo

Arm Intervention/Treatment
Experimental Alvimopan 0.5 mg Twice Daily (BID)
0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks.
Drug : alvimopan
Experimental Alvimopan 1 mg Once Daily (QD)
0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind. A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment.
Drug : alvimopan
Experimental Alvimopan 1 mg Once Daily (QD)
0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind. A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment.
Drug : placebo
Experimental Alvimopan 1 mg Twice Daily (BID)
0.5 mg of alvimopan was administered orally BID for 3 days, then 1 mg of alvimopan BID for the remaining 3 weeks.
Drug : alvimopan
Placebo Comparator Placebo
Placebo was administered orally BID for 3 weeks.
Drug : placebo

Recruitment Information

Recruitment Status:Completed
Enrollment233
Completion DateMay 01, 2006
Eligibility Criteria: Inclusion criteria:
- Participant is in any stage of cancer but has a minimum life expectancy of at least 3 months at the time of the Screening Visit.
- Participant is taking opioid therapy for persistent cancer pain.
- Participant meets the definition of opioid-induced bowel dysfunction as follows: Since starting opioid therapy, the subject has had decreased bowel movement (BM) frequency and at least one of the following constipation symptoms [sensation of incomplete evacuation, difficulty in expelling stool (straining), hard stools (abnormal stool consistency)].
- Participant understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities, including discontinuation of pre-study laxative regimen or other prohibited medications.
- Participant is able and willing to comply with a daily paper diary and is capable of completing paper questionnaires at study visits.
Exclusion criteria:
- Participant is pregnant or lactating, or planning to become pregnant.
- Participant is not ambulatory.
- Participant has participated in another trial with an investigational drug (unapproved), device or procedure within 30 days of the Screening Visit.
- Participant is unable to eat, drink, take/hold down oral medications.
- Participant is taking opioids for the management of drug addiction.
- Participant is unable or unwilling to discontinue the use of and/or refrain from using laxatives of all types and formulation at the Screening Visit and throughout the entire study.
- Participant has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation. This would include a subject who has reported no bowel movement for 7 consecutive days prior to the Screening Visit.
- Participant with gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
- Participant is currently taking vinca alkyloids or plans to take vinca alkyloids during the study.
- Participant is currently undergoing abdominal radiation therapy and/or plans to undergo abdominal radiation therapy during the study.
- Participant is human immunodeficiency virus (HIV)-infected, has active hepatitis (any subtype including ongoing chronic hepatitis B), or has ever been infected with hepatitis C.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Argentina
Australia
Canada
Czechia
Finland
France
Germany
Hong Kong
Hungary
India
Italy
Korea, Republic of
Netherlands
New Zealand
Pakistan
Peru
Philippines
Poland
Portugal
Russian Federation
South Africa
Spain
Taiwan
Thailand
United Kingdom
United States
Brazil
Czech Republic
Greece
Ireland

Administrative Information

NCT Number:NCT00101998
Other Study ID Numbers
3753-009
767905/008
NCT00903513
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