CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 282 enrolled
Drug / intervention
IW-3718 +2 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/NCT02637557
NCT02637557Phase 2Completed
CompareCT.gov

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Trial of IW-3718 Administered Orally for 8 Weeks to Patients With Symptomatic Gastroesophageal Reflux Disease Not Completely Responsive to Proton Pump Inhibitors

Ironwood Pharmaceuticals, Inc.·interventional·Posted Dec 22, 2015·Updated Oct 15, 2019

In Brief

A Phase 2 clinical trial evaluating IW-3718, Matching Placebo, and 1 other intervention for Gastroesophageal Reflux Disease. Completed, enrolled 282 participants across 62 sites.

Detailed Summary

The objectives of this study are to evaluate the safety, efficacy, and dose-response relationship of IW-3718 administered orally to participants who have GERD and continue to experience GERD symptoms while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 22, 2015
Enrollment StartMar 1, 2016
Primary CompletionApr 26, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.5 years ago

Interventions

IW-3718drug

Matching Placebodrug

PPIdrug

All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium sesquihydrate, rabeprazole or rabeprazole sodium) during the study.