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

Opioid-Induced Constipation Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Constipation
• Opioid-Induced Constipation

• NCT number: NCT01696643
• Study type: Interventional
• Source: Cubist Pharmaceuticals LLC
• Status: Terminated
• Phase: Phase 3
• Start date: October 12, 2012
• Completion date: July 21, 2014