Phase 3 Study of TAK-438 10 mg in the Treatment of Non-Erosive Gastroesophageal Reflux Disease (NERD)

Summary

The purpose of this study was to evaluate the efficacy and safety of oral TAK-438 10 mg once-daily in the treatment of non-erosive gastroesophageal reflux disease (NERD).

Timeline

Start

2016-11-15

Primary completion

2018-02-25

Completion

2018-02-26

Outcome

Mixed primary results

registry analysis (superiority test); Placebo vs TAK-438 10 mg; p = 0.0643; Median Difference (Final Values) 3.800 (95% CI 0.000 to 10.600); Wilcoxon Rank-Sum Test NCT02954848 ↗

registry analysis (superiority test); Placebo vs TAK-438 10 mg; p = 0.0003; Log Rank NCT02954848 ↗

registry analysis (superiority test); Placebo vs TAK-438 10 mg; p = 0.0826; Median Difference (Final Values) -0.1100 (95% CI -0.2400 to 0.0100); Wilcoxon Rank-Sum Test NCT02954848 ↗

Publications

• Kinoshita Y, Sakurai Y, Takabayashi N, Kudou K, Araki T, Miyagi T, Iwakiri K, Ashida K. Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study. Clin Transl Gastroenterol. 2019 Nov;10(11):e00101. doi: 10.14309/ctg.0000000000000101.

Drugs

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

Indications