NCT02270983

Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered Orally for 8 Weeks to Adult Outpatients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment for chronic non-cancer pain that has been present for a minimum of 3 months. This study included up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients meeting the entry criteria were randomized to 1 of 2 doses of linaclotide or placebo once per day for 8 weeks. This 8-week study assessed the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of OIC.

Conditions

• Opioid-Induced Constipation

Interventions

Type	Name	Description
DRUG	Linaclotide 145 micrograms
DRUG	Linaclotide 290 micrograms
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2014-10-31
• Primary completion: 2015-08-31
• Completion: 2015-10-31
• First posted: 2014-10-22
• Last updated: 2019-04-08
• Results posted: 2019-04-08

Locations

77 sites across 1 country: United States