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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Collaborator: GlaxoSmithKline
• Treatments: Alvimopan; Analgesics, Opioid

Criteria

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.