At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 643 enrolled
Drug / intervention
Matching Placebo +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 Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Chronic Constipation
In Brief
A Phase 3 clinical trial evaluating Matching Placebo and Linaclotide for Chronic Constipation. Completed, enrolled 643 participants across 105 sites.
Detailed Summary
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients 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 Constipation
CountriesUnited States
CollaboratorsForest Laboratories
Timeline
Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
First PostedAug 2008
Primary CompletionAug 2009
Study CompletionOct 2009
TodayJul 2026
First PostedAug 8, 2008
Enrollment StartAug 1, 2008
Primary CompletionAug 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.9 years ago
Interventions
Matching Placebodrug
Oral, once daily
Linaclotidedrug
Oral, once daily