CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 633 enrolled
Drug / intervention
Linaclotide 290 micrograms +2 moredrug
Likely dose
Linaclotide 290 microgramsfrom 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.

Search/NCT00765882
NCT00765882Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks in Patients With Chronic Constipation

Forest Laboratories·interventional·Posted Oct 3, 2008·Updated Jan 30, 2013

In Brief

A Phase 3 clinical trial evaluating Linaclotide 290 micrograms, Linaclotide 145 micrograms, and 1 other intervention for Chronic Constipation. Completed, enrolled 633 participants across 108 sites in 2 countries.

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 treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Constipation
CountriesCanada, United States
CollaboratorsIronwood Pharmaceuticals, Inc.

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 3, 2008
Enrollment StartSep 1, 2008
Primary CompletionJul 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.7 years ago

Interventions

Linaclotide 290 microgramsdrug

Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Linaclotide 145 microgramsdrug

Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Placebodrug

Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study