Conditions: Esophagitis, Reflux Esophagitis, Peptic
Keywords: Erosive Esophagitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2054
Healthy volunteers: no

Brief 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.

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: