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
Sponsored by: AstraZeneca
Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca
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.
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.
Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.
Safety and tolerability of the treatments for 8 weeks of treatment.
Minimum age: 18 Years.
Maximum age: N/A.
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.
1. History of esophageal, gastric or duodenal surgery, except for simple closure of an
2. History of severe liver disease, including (but not limited to) cirrhosis and acute or
3. Other conditions and criteria, as specified in the protocol.
Locations and Contacts
Starting date: February 2001
Ending date: June 2003
Last updated: March 11, 2008