Conditions: Esophagitis, Reflux Esophagitis, Peptic
Keywords: Erosive Esophagitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2038
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Dexlansoprazole MR intervention 2: Dexlansoprazole MR intervention 3: Lansoprazole
Intervention descriptions: intervention 1: Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks. intervention 2: Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks. intervention 3: Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Protocol document: