drugset / Trial / NCT01474369

Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease

NCT01474369 ↗

Phase 3 Completed 827 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to investigate the superiority of efficacy of TAK-438, once daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease.

Timeline

Start
2011-12
Primary completion
2013-02
Completion
2013-02

Outcome

Missed primary endpoint

paper Vonoprazan at doses of 10 mg and 20 mg are not superior to placebo with respect to proportion of days without heartburn PMID 28119763 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Vonoprazan Other / unclassified 10 mg Oral
Subject Vonoprazan Other / unclassified 20 mg Oral