NCT00251693

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: 2,038 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg 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 QD and 90 mg QD) 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 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

140 sites across 15 countries: United States, Australia, Bulgaria, Canada, Czechia, Germany, Hungary, India, Latvia, Lithuania, New Zealand, Peru, Poland, Slovakia, South Africa