NCT01474369

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

A Phase 3, Randomized, Double Blind, Placebo Control, Multicenter Study to Evaluate the Efficacy and Safety of TAK- 438 (10 and 20 mg Once-Daily) in Patients With Non-Erosive Gastroesophageal Reflux Disease.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 827 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-erosive Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	TAK-438	TAK-438 10 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.
DRUG	TAK-438	TAK-438 20 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.
DRUG	Placebo	TAK-438 placebo-matching tablets, orally, once daily for 5 weeks.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-11-18
• Last updated: 2013-07-03

Locations

52 sites across 1 country: Japan