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
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 for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once
daily; or ranitidine 150 mg twice daily for subjects in the US only.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The proportion of patients with no gastric ulcers after 8 weeks of treatment.
Secondary outcome: The patient and investigator symptoms, defined as control of NSAID-associated GI symptoms up to 8 weeks of treatment with esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily NTo look at any side effects of esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily NSAID therapy.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Additional Information
Starting date: February 2001
Ending date: May 2003
Last updated: March 11, 2008
|
