Clinical Trial: Reflux Esophagitis Phase III Study (Maintenance 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 Once Daily Oral Administration With Omeprazole 10 mg and Esomeprazol

Brief Summary: The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. [ Time Frame: Up to 24 weeks ]

Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.


Original Primary Outcome: Presence/absence of recurrence of Reflux Esophagitis according to Los Angeles classification. [ Time Frame: throughout the treatment period ]

Current Secondary Outcome:

  • Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment [ Time Frame: up to 4 weeks ]
    Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated.
  • Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment [ Time Frame: Up to 12 weeks ]
    Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.


Original Secondary Outcome: Presence/absence of recurrence of Reflux Esophagitis according to Los Angeles classification. [ Time Frame: at Week 4 or before and Week 12 or before ]

Information By: AstraZeneca

Dates:
Date Received: March 4, 2008
Date Started: January 2008
Date Completion:
Last Updated: May 18, 2010
Last Verified: May 2010