CompletedPhase 3

Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

United States805 participantsStarted 2005-08-01

Plain-language 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) 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * 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). Exclusion criteria: * 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.

What they're measuring

To compare alvimopan with placebo for long-term safety and tolerability

Timeframe: 12 months

Trial details

NCT IDNCT00241722

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-02-01