NCT01452698

Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (20 mg Once-Daily) Compared to AG-1749 (30mg Once-Daily) in Patients With Erosive Esophagitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 409 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.

Conditions

• Erosive Esophagitis

Interventions

Type	Name	Description
DRUG	TAK-438	TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
DRUG	Placebo	Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.
DRUG	Lansoprazole	Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.
DRUG	Placebo	TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.

Timeline

• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-10-17
• Last updated: 2012-11-09

Locations

32 sites across 1 country: Japan