CompletedPhase 3

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

400 participantsStarted 2001-02

Plain-language 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.

Who can participate

Age range18 Years

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Inclusion criteria

✓. A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
✓. 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.
✕. Other conditions and criteria, as specified in the protocol.

What they're measuring

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.

Trial details

NCT IDNCT00633672

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-10

View on ClinicalTrials.gov More NSAID Associated Gastric Ulcers trials