CompletedPhase 3

Prevention of Gastric Ulcers

504 participantsStarted 2001-03

Plain-language summary

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention 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; versus placebo; in patients at risk.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. No gastric or duodenal ulcer on baseline endoscopy.
✓. A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
✓. Other inclusion criteria, as defined in the protocol.

Exclusion criteria

✕. History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer.
✕. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
✕. Other criteria, as defined in the protocol.

What they're measuring

To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of the treatment for the prevention of gastric (and/or duodenal) ulcers in patients receiving daily NSAID therapy and being at risk

Timeframe: Assessments at Week 0, Week 4, Week 12, Week 26

Trial details

NCT IDNCT00629512

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2002-12

View on ClinicalTrials.gov More NSAID Associated Gastric Ulcers trials