Status:
COMPLETED
Reflux Esophagitis Phase III Study (Maintenance Treatment)
Lead Sponsor:
AstraZeneca
Conditions:
Reflux Esophagitis
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 compari...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00634114
Start Date
January 1 2008
End Date
May 1 2009
Last Update
June 17 2010
Active Locations (44)
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1
Research Site
Akita, Akita, Japan
2
Research Site
Kashiwa, Chiba, Japan
3
Research Site
Kisarazu, Chiba, Japan
4
Research Site
Kōriyama, Fukishima, Japan