CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 484 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
TAK-438 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02954848
NCT02954848Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-438 10 mg Once-daily in the Treatment of Non-Erosive Gastroesophageal Reflux Disease

Takeda·interventional·Posted Nov 4, 2016·Updated Aug 2, 2019

In Brief

A Phase 3 clinical trial evaluating Placebo and TAK-438 10 mg for Non-erosive Gastroesophageal Reflux Disease. Completed, enrolled 484 participants across 30 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-erosive Gastroesophageal Reflux Disease
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 4, 2016
Enrollment StartNov 15, 2016
Primary CompletionFeb 25, 2018
Study CompletionFeb 26, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.7 years ago

Interventions

Placebodrug

TAK-438 placebo-matching tablets

TAK-438 10 mgdrug

TAK-438 tablets