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
NCT00633412 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2009-06-11
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.
Conditions
- NSAID Associated Gastric Ulcers
Interventions
- DRUG
-
Esomeprazole
20mg oral daily
- DRUG
-
Ranitidine
150mg oral twice daily
- DRUG
-
Esomeprazole
40mg oral tablet daily
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Paula Fernstrom · Nexium Global Product Director, AstraZeneca
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-02-28
- Completion
- 2003-03-31
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