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NCT00256932 · ClinicalTrials.gov registry record · Phase 3
Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
A Phase 3 study of Constipation and Bowel Dysfunction, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 3
- Development phase
- 518
- Enrollment target
- 20
- Study locations
NCT00256932: Completed Phase 3 study of Constipation and Bowel Dysfunction, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT00256932 is a Phase 3 study of Constipation and Bowel Dysfunction that has completed, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 518 participants, above the 196-participant average among 54 other Constipation trials with a reported enrollment target (164% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00256932, a Phase 3 study of Constipation and Bowel Dysfunction, has completed, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 518 participants
- Enrollment target
- 20
- Study locations
Study Summary
Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG alvimopan
Study Locations (20)
California
- GSK Investigational Site - Anaheim
- GSK Investigational Site - Anaheim
- GSK Investigational Site - Beuna Park
- GSK Investigational Site - Burbank
- GSK Investigational Site - Duarte
- GSK Investigational Site - Fountain Valley
- GSK Investigational Site - Huntington Beach
Arizona
- GSK Investigational Site - Glendale
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Sun City
- GSK Investigational Site - Tucson
- GSK Investigational Site - Tucson
Alabama
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Calera
- GSK Investigational Site - Muscle Shoals
- GSK Investigational Site - Tallassee
Arkansas
- GSK Investigational Site - Hot Springs
- GSK Investigational Site - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 518 participants |
| Start Date | 2005-08 |
| Est. Completion | 2006-05 |
| Phase | Phase 3 |
Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)42 total trials
What the finished NCT00256932 record still lists
NCT00256932 is an interventional study that assigns participants to a tested intervention. The registered 518 participants enrollment target is mid-sized for trials with a published cap, above the 196-participant average among 54 other Constipation trials with a reported enrollment target (164% higher).
The record links to 2 conditions, with Constipation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00256932 names 20 study sites across 4 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT00256932 about?
NCT00256932 is a clinical study titled "Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain". Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy ...
What is the current status of trial NCT00256932?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 518 participants. The study started on 2005-08. Estimated completion is 2006-05.
What conditions does trial NCT00256932 study?
This clinical trial studies the following conditions: Constipation, Bowel Dysfunction.
What interventions are being tested in trial NCT00256932?
The interventions under investigation include: Placebo (DRUG), alvimopan (DRUG).
Who is sponsoring clinical trial NCT00256932?
This trial is sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00256932 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Constipation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00256932's enrollment target sits among peer trials
518 3rd of 54 higher than 52 of 54 other Constipation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Constipation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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