NCT01696643

Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation

Phase 3 Study to Evaluate the Long-Term Safety and Tolerability of CB-5945 for the Treatment of Opioid-Induced Constipation in Adults Taking Opioid Therapy for Chronic Non-Cancer Pain

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,407 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.

Detailed description

This is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with OIC taking opioid therapy for chronic non-cancer pain. Approximately 1,400 participants (approximately 700 participants per treatment group) with OIC will be randomized at approximately 225 study centers to receive either 0.25 milligrams (mg) CB-5945 twice daily (BID) or a matching placebo BID for the 52-week double-blind treatment period, followed by a 4-week follow-up period. All randomized participants will be evaluated for safety, tolerability, and quality of life from the first dose of study drug through Week 56.

Conditions

• Opioid-Induced Constipation

Interventions

Type	Name	Description
DRUG	CB-5945
DRUG	Placebo

Timeline

• Start date: 2012-10-12
• Primary completion: 2014-07-21
• Completion: 2014-07-21
• First posted: 2012-10-01
• Last updated: 2018-11-15
• Results posted: 2015-09-28