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

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

2018-06-20

Primary completion

2020-10-07

Completion

2020-11-03

Outcome

Missed primary endpoint

Stopped: “Parallel IW-3718 Phase III trial did not meet pre-specified criteria.”

registry analysis (superiority test); Placebo BID + PPI vs 1500 mg IW-3718 BID + PPI; p = 0.6346; Least squares (LS) mean difference 0.055 (95% CI -0.172 to 0.281); MMRM NCT03561090 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Colesevelam	Other / unclassified	1500 mg	Oral

Indications