Alvimopan For The 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 of 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

NCT00259922

Run by

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

485

Starts

2005-08-01

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…

• 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 — Huntsville, Alabama, United States
• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Northport, Alabama, United States
• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Tempe, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Bakersfield, California, United States
• GSK Investigational Site — Beverly Hills, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Gatos, California, United States
• GSK Investigational Site — Northridge, California, United States
• GSK Investigational Site — Orange, California, United States
• GSK Investigational Site — Palm Springs, California, United States
• GSK Investigational Site — Pasadena, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Rafael, California, United States
• GSK Investigational Site — Santa Ana, California, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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