NCT00251719

Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg Once-daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,054 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.

Detailed description

This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (60 mg and 90 mg) with that of Lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last up to 8 weeks.

Conditions

• Esophagitis, Reflux
• Esophagitis, Peptic

Interventions

Type	Name	Description
DRUG	Dexlansoprazole MR	Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
DRUG	Dexlansoprazole MR	Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
DRUG	Lansoprazole	Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-11-10
• Last updated: 2012-02-03
• Results posted: 2009-03-23

Locations

144 sites across 16 countries: United States, Australia, Bulgaria, Canada, Colombia, Czechia, Germany, India, Latvia, Lithuania, New Zealand, Peru, Poland, Russia, Slovakia, South Africa