Status:
COMPLETED
A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued in Subjects in the US Only
Lead Sponsor:
AstraZeneca
Conditions:
NSAID Associated Gastric Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups for u...
Eligibility Criteria
Inclusion
- A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
- A gastric ulcer \>= 5mm in diameter, but no ulcer \>25 mm at its greatest diameter, at the baseline endoscopy.
- Other key inclusion criteria, as specified in the protocol.
Exclusion
- History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
- History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- Many other conditions and criteria, as specified in the protocol.
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2003
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00633412
Start Date
February 1 2001
End Date
March 1 2003
Last Update
June 11 2009
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