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 Esomeprazole 10 mg Once Daily Oral Administration in Maintenance Treatment in Patients With Healed Reflux Esophagitis”

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
  • 10mg once daily oral administration
• Drug: Esomeprazole
  • 20mg once daily oral administration
• Drug: Omeprazole
  • 10mg once daily oral administration

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Esomeprazole and Omeprazole
• Experimental: 2
  • Esomeprazole

Primary Measures

• Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.
  • Time Frame: Up to 24 weeks
    Safety Issue?: No

Secondary Measures

• Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment
  • Time Frame: up to 4 weeks
    Safety Issue?: No
• Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment
  • Time Frame: Up to 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patients with healed Reflux Esophagitis verified by EGD in the preceding study (D961HC00002)
• Patients with endoscopically verified healed Reflux Esophagitis by EGD receiving general treatment with PPI

Exclusion Criteria:

• Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation.
• Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Maotsugu Oyama, MD, PhD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00634114

Study ID Number: D961HC00006

ClinicalTrials.gov Identifier: NCT00634114

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency