A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

Phase 2 Completed 458 enrolled Phathom Pharmaceuticals, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in relief of episodic heartburn over 6 weeks in participants with symptomatic non-erosive gastroesophageal reflux disease (NERD), and to assess the safety of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in participants with symptomatic NERD.

Timeline

Start: 2021-03-25
Primary completion: 2021-12-16
Completion: 2022-01-17

Outcome

Met primary endpoint

paper compared with 27.3% (101/370) in the placebo group (p < 0.0001 versus placebo for each vonoprazan group). PMID 37750406 ↗

Publications

Fass R, Vaezi M, Sharma P, Yadlapati R, Hunt B, Harris T, Smith N, Leifke E, Armstrong D. Randomised clinical trial: Efficacy and safety of on-demand vonoprazan versus placebo for non-erosive reflux disease. Aliment Pharmacol Ther. 2023 Nov;58(10):1016-1027. doi: 10.1111/apt.17728. Epub 2023 Sep 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vonoprazan	Other / unclassified	10 mg	Oral
Subject	Vonoprazan	Other / unclassified	20 mg	Oral
Subject	Vonoprazan	Other / unclassified	40 mg	Oral