drugset / Trial / NCT03561883

Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)

NCT03561883 ↗

Phase 3 Completed 609 enrolled Ironwood Pharmaceuticals, Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2018-09-06
Primary completion
2020-07-28
Completion
2020-11-06

Outcome

Missed primary endpoint

registry p = 0.5566; Least squares (LS) mean difference -0.062 (95% CI -0.270 to 0.146) NCT03561883 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Colesevelam Other / unclassified 1500 mg Oral