At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation
In Brief
A Phase 3 clinical trial evaluating Linaclotide 290 micrograms and Matching placebo for Irritable Bowel Syndrome Characterized by Constipation. Completed, enrolled 803 participants across 118 sites in 2 countries.
Detailed Summary
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.
Study Details
Timeline
Interventions
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study