A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)

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).

Timeline

Start

2016-03-01

Primary completion

2017-04-26

Completion

2017-04-26

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo BID vs 1500 mg IW-3718 BID; p = 0.0400; LS Mean Difference -11.943 (95% CI -23.334 to -0.551); NCT02637557 ↗

paper The treatment difference was 11.9% between the 1500 mg IW-3718 and placebo groups (P = .04, analysis of covariance). PMID 32092310 ↗

Publications

• Vaezi MF, Fass R, Vakil N, Reasner DS, Mittleman RS, Hall M, Shao JZ, Chen Y, Lane L, Gates AM, Currie MG. IW-3718 Reduces Heartburn Severity in Patients With Refractory Gastroesophageal Reflux Disease in a Randomized Trial. Gastroenterology. 2020 Jun;158(8):2093-2103. doi: 10.1053/j.gastro.2020.02.031. Epub 2020 Feb 22.
• Andrae DA, Hanlon J, Cala ML, Scippa K, Graham C, Witherspoon B, Shao JZ, Reasner D. Evaluation and Validation of the Modified Reflux Symptom Questionnaire-Electronic Diary in Patients With Persistent Gastroesophageal Reflux Disease. Clin Transl Gastroenterol. 2020 Jan;11(1):e00117. doi: 10.14309/ctg.0000000000000117.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Colesevelam	Other / unclassified	500 mg	Oral
Subject	Colesevelam	Other / unclassified	1000 mg	Oral
Subject	Colesevelam	Other / unclassified	1500 mg	Oral
Background	Dexlansoprazole	Other / unclassified	—	—
Background	Esomeprazole	Small molecule	—	—
Background	Lansoprazole	Other / unclassified	—	—
Background	Omeprazole	Other / unclassified	—	—
Background	Pantoprazole	Other / unclassified	—	—
Background	Rabeprazole	Small molecule	—	—

Indications