NCT00321737

Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis

A Phase 3 Study to Evaluate the Safety and Efficacy of TAK-390MR (30 mg QD and 60 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 445 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the ability of once-daily (QD) treatment with dexlansoprazole modified release (MR) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).

Detailed description

This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily dexlansoprazole MR (30 mg and 60 mg) with that of placebo, in maintaining healing of EE.

Conditions

• Esophagitis, Reflux
• Esophagitis, Peptic

Interventions

Type	Name	Description
DRUG	Dexlansoprazole MR	Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months.
DRUG	Dexlansoprazole MR	Dexlansoprazole MR 60 mg, orally, once daily for up to six months.
DRUG	Placebo	Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-05-04
• Last updated: 2012-02-03
• Results posted: 2009-08-28

Locations

98 sites across 8 countries: United States, Australia, Canada, Czechia, Estonia, Latvia, Lithuania, Slovakia