drugset / Trial / NCT05195528
A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg and 20 mg once daily \[QD\]) compared to placebo (QD) in relief of heartburn over 4 weeks in participants with NERD.
Timeline
- Start
- 2022-01-17
- Primary completion
- 2022-11-21
- Completion
- 2023-05-17
Publications
- Antunes C, Ghosh G, Katz P, Yadlapati R, Leifke E, Harris T, Graham H, Laine L. Vonoprazan Improves Nocturnal Gastroesophageal Reflux Symptoms in Nonerosive Reflux Disease. Am J Gastroenterol. 2025 Oct 13. doi: 10.14309/ajg.0000000000003794. Online ahead of print.
- Laine L, Spechler S, Yadlapati R, Schnoll-Sussman F, Smith N, Leifke E, Harris T, Hunt B, Fass R, Katz P. Vonoprazan is Efficacious for Treatment of Heartburn in Non-erosive Reflux Disease: A Randomized Trial. Clin Gastroenterol Hepatol. 2024 Nov;22(11):2211-2220.e10. doi: 10.1016/j.cgh.2024.05.004. Epub 2024 May 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vonoprazan | Other / unclassified | 10 mg | Oral |
| Subject | Vonoprazan | Other / unclassified | 20 mg | Oral |