Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
Completed · Phase 3 · Has a placebo group
Conditions studied: Bowel Dysfunction, Constipation
In brief
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.
Key facts
- Study ID
- NCT00256932
- Run by
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- People needed
- 518
- Starts
- 2005-08-01
- Expected to finish
- 2006-05-01
- Last updated by the study team
- 2015-09-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has consented to participate in this study.
- Taking opioid therapy for persistent non-cancer pain.
- Has bowel dysfunction mainly due to opioids.
- Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms.
- Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed).
- Willing to report daily bowel symptoms.
You may not qualify if…
- Pregnant, lactating, or planning to become pregnant.
- Not ambulatory.
- Participated in another trial with an investigational drug in the past 30 days.
- Taking opioids for the management of drug addiction or cancer-related pain.
- Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation.
- Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
- HIV-infected, has active hepatitis, or has ever been infected with hepatitis C.
Where it is running
- GSK Investigational Site — Birmingham, Alabama, United States
- GSK Investigational Site — Calera, Alabama, United States
- GSK Investigational Site — Muscle Shoals, Alabama, United States
- GSK Investigational Site — Tallassee, Alabama, United States
- GSK Investigational Site — Glendale, Arizona, United States
- GSK Investigational Site — Phoenix, Arizona, United States
- GSK Investigational Site — Phoenix, Arizona, United States
- GSK Investigational Site — Sun City, Arizona, United States
- GSK Investigational Site — Tucson, Arizona, United States
- GSK Investigational Site — Tucson, Arizona, United States
- GSK Investigational Site — Hot Springs, Arkansas, United States
- GSK Investigational Site — Little Rock, Arkansas, United States
- GSK Investigational Site — Anaheim, California, United States
- GSK Investigational Site — Anaheim, California, United States
- GSK Investigational Site — Beuna Park, California, United States
- GSK Investigational Site — Burbank, California, United States
- GSK Investigational Site — Duarte, California, United States
- GSK Investigational Site — Fountain Valley, California, United States
- GSK Investigational Site — Huntington Beach, California, United States
- GSK Investigational Site — Mission Viejo, California, United States
- GSK Investigational Site — Orange, California, United States
- GSK Investigational Site — Redlands, California, United States
- GSK Investigational Site — San Diego, California, United States
- GSK Investigational Site — San Diego, California, United States
- GSK Investigational Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.