drugset / Trial / NCT02637557
A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
RandomizedParallel-groupDouble-blindTreatment
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
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 | — | — |