CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 609 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/NCT03561883
NCT03561883Phase 3Completed

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients With Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors

Ironwood Pharmaceuticals, Inc.·interventional·Posted Jun 19, 2018·Updated Aug 18, 2021

In Brief

A Phase 3 clinical trial evaluating IW-3718, placebo, and 1 other intervention for Gastroesophageal Reflux Disease (GERD). Completed, enrolled 609 participants across 101 sites in 2 countries.

Detailed Summary

The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard dose PPIs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 19, 2018
Enrollment StartSep 6, 2018
Primary CompletionJul 28, 2020
Study CompletionNov 6, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.0 years ago

Interventions

IW-3718drug

oral tablet

placebodrug

oral tablet

Standard-dose PPIs QDdrug

background therapy