NCT00241722

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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate Long-Term Safety and Efficacy of Alvimopan 0.5mg Twice Daily for 12 Months for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 805 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bowel Dysfunction
• Constipation

Interventions

Type	Name	Description
DRUG	Alvimopan
DRUG	Placebo

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2005-10-19
• Last updated: 2017-08-30

Locations

227 sites across 17 countries: United States, Australia, Austria, Canada, Denmark, Finland, Hong Kong, Hungary, Ireland, Netherlands, New Zealand, Poland, Spain, Sweden, Switzerland, Taiwan, United Kingdom