CompletedPhase 3

Ulcer Prevention II

800 participantsStarted 2001-02

Plain-language summary

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. No active/current 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.

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 treatment for the prevention of gastric (and duodenal) ulcers in patients receiving daily NSAID therapy.

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

Trial details

NCT IDNCT00629928

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-03

View on ClinicalTrials.gov More NSAID Associated Gastric Ulcers trials