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

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Esomeprazole; Ranitidine; Ranitidine bismuth citrate

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.