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 Daily Oral Administration in Patients With Reflux Esophagitis”

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 .

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
  • 20mg once daily
• Drug: Esomeprazole
  • 40 mg once daily
• Drug: Omeprazole
  • 20mg once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Esomeprazole 20mg and Omeprazole 20mg
• Experimental: 2
  • Esomeprazole 40mg and Omeprazole 20mg

Primary Measures

• Presence/absence of Reflux Esophagitis according to Los Angeles classification
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Presence/absence of Reflux Esophagitis according to Los Angeles classification.
  • Time Frame: 4 weeks
    Safety Issue?: No

Inclusion Criteria:

• Endoscopically verified Reflux Esophagitis classified into Los Angeles classification
• Grade A, B, C or D within 1 week before randomisation

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  

Overall Contact: AstraZeneca KK Corporate Communications +81 6 6453 8011 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00633932

Study ID Number: D961HC00002

ClinicalTrials.gov Identifier: NCT00633932

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency