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
Lead Sponsor:
AstraZeneca
Conditions:
NSAID Associated Gastric Ulcers
Eligibility:
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: esom...
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.
- 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.
- Other conditions and criteria, as specified in the protocol.
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2003
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00633672
Start Date
February 1 2001
End Date
October 1 2003
Last Update
January 25 2011
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