NCT00259922

Alvimopan For The 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 the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks 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: 485 (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 (1:1:1) 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.

Conditions

• Bowel Dysfunction
• Constipation

Interventions

Type	Name	Description
DRUG	Placebo	Placebo
DRUG	Alvimopan	0.5 mg QD
DRUG	Alviompan	0.5 mg BID

Timeline

• Start date: 2005-08-01
• Primary completion: 2006-06-01
• First posted: 2005-12-01
• Last updated: 2015-09-02

Locations

187 sites across 12 countries: United States, Australia, Canada, France, Hungary, Netherlands, New Zealand, Norway, South Africa, Spain, Sweden, Switzerland