At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Linaclotide 290 micrograms, Linaclotide 145 micrograms, and 1 other intervention for Chronic Constipation and Constipation. Completed, enrolled 487 participants across 151 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
oral capsule, taken once daily each morning at least 30 minutes before breakfast
oral capsule, taken once daily each morning at least 30 minutes before breakfast
oral capsule, taken once daily each morning at least 30 minutes before breakfast