drugset / Trial / NCT02873689

Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients

NCT02873689 ↗

Phase 3 Completed 217 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine the efficacy and safety of dexlansoprazole compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in Chinese participants with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD).

Timeline

Start
2016-12-27
Primary completion
2018-03-14
Completion
2018-04-19

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Dexlansoprazole 30 mg; p = 0.057; Wilcoxon rank-sum test NCT02873689 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexlansoprazole Other / unclassified 30 mg Oral