NCT02954848

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 484 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Non-erosive Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	Placebo	TAK-438 placebo-matching tablets
DRUG	TAK-438 10 mg	TAK-438 tablets

Timeline

• Start date: 2016-11-15
• Primary completion: 2018-02-25
• Completion: 2018-02-26
• First posted: 2016-11-04
• Last updated: 2019-08-02
• Results posted: 2019-08-02

Locations

30 sites across 1 country: Japan