CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 759 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.

Search/NCT02559206
NCT02559206Phase 2Completed
CompareCT.gov

A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation

Ironwood Pharmaceuticals, Inc.·interventional·Posted Sep 24, 2015·Updated Apr 24, 2020

In Brief

A Phase 2 clinical trial evaluating Linaclotide and Matching Placebo for Irritable Bowel Syndrome With Constipation. Completed, enrolled 759 participants across 71 sites.

Detailed Summary

The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release \[IR\] formulation of linaclotide).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome With Constipation
CountriesUnited States
CollaboratorsForest Laboratories

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 24, 2015
Enrollment StartOct 22, 2015
Primary CompletionSep 30, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.8 years ago

Interventions

Linaclotidedrug

Oral, once daily

Matching Placebodrug

Oral, once daily