Comparison of Vonoprazan to Esomeprazole in Participants With Symptomatic GERD Who Responded Partially to a High Dose of Proton Pump Inhibitor (PPI)

Summary

The purpose of this study is to determine the effect of vonoprazan compared to esomeprazole for preventing heartburn symptoms over a 4-week treatment period in participants who have a partial response to treatment with esomeprazole.

Timeline

Start

2016-07-14

Primary completion

2018-10-05

Completion

2018-10-12

Outcome

Missed primary endpoint

registry analysis (superiority test); Esomeprazole 40 mg vs Vonoprazan 20 mg; p = 0.7480 NCT02743949 ↗

registry analysis (superiority test); Esomeprazole 40 mg vs Vonoprazan 40 mg; p = 0.5985 NCT02743949 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Esomeprazole	Small molecule	40 mg	Oral
Subject	Vonoprazan	Other / unclassified	20 mg	Oral
Subject	Vonoprazan	Other / unclassified	40 mg	Oral

Indications