At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,223 enrolled
Drug / intervention
Linaclotide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 ug or 145 ug) Administered Orally for 12 Weeks to Patients With Chronic Idiopathic Constipation
In Brief
A Phase 3 clinical trial evaluating Linaclotide and Matching Placebo for Chronic Idiopathic Constipation. Completed, enrolled 1,223 participants across 95 sites.
Detailed Summary
The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Idiopathic Constipation
CountriesUnited States
CollaboratorsForest Laboratories
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedNov 2014
Primary CompletionAug 2015
TodayJul 2026
First PostedNov 14, 2014
Enrollment StartOct 1, 2014
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.6 years ago
Interventions
Linaclotidedrug
Matching Placebodrug