NCT01642914

Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating

Phase 3b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Chronic Constipation and Prominent Abdominal Bloating at Baseline

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 487 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.

Conditions

• Chronic Constipation
• Constipation

Interventions

Type	Name	Description
DRUG	Linaclotide 290 micrograms	oral capsule, taken once daily each morning at least 30 minutes before breakfast
DRUG	Linaclotide 145 micrograms	oral capsule, taken once daily each morning at least 30 minutes before breakfast
DRUG	Matching placebo	oral capsule, taken once daily each morning at least 30 minutes before breakfast

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-05-01
• Completion: 2013-08-01
• First posted: 2012-07-17
• Last updated: 2016-04-26
• Results posted: 2016-04-26

Locations

151 sites across 2 countries: United States, Canada