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
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: NSAID Associated Gastric Ulcers
Intervention: Esomeprazole (Drug); Ranitidine (Drug); Esomeprazole (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca
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: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine
150 mg twice daily.
Clinical Details
Official title: 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
Study design: Treatment, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To assess the safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers.
Secondary outcome: Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.Safety and tolerability of the treatments for 8 weeks of treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid
arthritis) that requires daily NSAID treatment for at least 2 months.
2. Other key inclusion criteria, as specified in the protocol.
Exclusion Criteria:
1. History of esophageal, gastric or duodenal surgery, except for simple closure of an
ulcer.
2. History of severe liver disease, including (but not limited to) cirrhosis and acute or
chronic hepatitis.
3. Other conditions and criteria, as specified in the protocol.
Locations and Contacts
Additional Information
Starting date: February 2001
Ending date: June 2003
Last updated: March 11, 2008
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