Long-Term Safety Evaluation Of 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) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.

Key facts

Study ID

NCT00241722

Run by

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

People needed

805

Starts

2005-08-01

Expected to finish

2007-02-01

Last updated by the study team

2017-08-30

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).

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.
• Human Immunodeficiency Virus (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 — Birmingham, Alabama, United States
• GSK Investigational Site — Huntsville, Alabama, United States
• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Muscle Shoals, Alabama, United States
• GSK Investigational Site — Northport, 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 — Phoenix, Arizona, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Sun City, 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 — 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 — Bakersfield, California, United States
• GSK Investigational Site — Beverly Hills, California, United States
• GSK Investigational Site — Buena Park, California, United States
• GSK Investigational Site — Burbank, 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.