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

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)1 site in 1 country805 target enrollmentAugust 1, 2005

ConditionsBowel Dysfunction Constipation

InterventionsAlvimopan Placebo

DrugsAlvimopan Placebo

Overview

Phase: Phase 3
Intervention: Alvimopan
Conditions: Bowel Dysfunction
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Enrollment: 805
Locations: 1
Primary Endpoint: To compare alvimopan with placebo for long-term safety and tolerability
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 1, 2005

End Date

February 1, 2007

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel