Non-erosive Gastroesophageal Reflux Disease Clinical Trial
Official title:
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
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).
A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multi-center study
will be conducted to verify the superiority of TAK-438 (TAK-438 10 mg, once daily, 4 weeks)
to placebo (placebo, once daily, 4 weeks) in participants with non-erosive gastroesophageal
reflux disease (NERD).
The study consists of a 1-week, single-blind run-in period and a 4-week, double-blind
treatment period. The participants will receive the study drug (TAK-438 placebo tablet) for
the 1-week single-blind run-in period. After the run-in period, eligible participants will be
randomized into TAK-438 10 mg or placebo treatment groups in a 1:1 ratio. The randomized
participants will receive the assigned study drug (TAK-438 10 mg tablet or placebo tablet)
for the 4-week double-blind treatment period.
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