Clinical Trial: Reflux Esophagitis Phase III Study (Initial Treatment)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg and 40 mg Once Daily Oral Administration With Omeprazole 20 mg Once
Brief Summary: This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles classification .
Detailed Summary:
Sponsor: AstraZeneca
Current Primary Outcome: Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification". [ Time Frame: 8 weeks ]
Original Primary Outcome: Presence/absence of Reflux Esophagitis according to Los Angeles classification [ Time Frame: 8 weeks ]
Current Secondary Outcome: Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification [ Time Frame: 4 weeks ]
Original Secondary Outcome: Presence/absence of Reflux Esophagitis according to Los Angeles classification. [ Time Frame: 4 weeks ]
Information By: AstraZeneca
Dates:
Date Received: March 4, 2008
Date Started: December 2007
Date Completion:
Last Updated: December 2, 2010
Last Verified: December 2010