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)

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

Outcome

Met primary endpoint

paper the percentage of 24-hour heartburn-free days was 27.7% for placebo vs 44.8% for vonoprazan 10 mg (least squares mean difference, 17.1%; P < .0001) PMID 38750866 ↗

paper 44.4% for vonoprazan 20 mg (least squares mean difference, 16.7%; P < .0001) PMID 38750866 ↗

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

Indications