CompletedPhase 3

Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

Japan343 participantsStarted 2007-08

Plain-language summary

The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Medical history of gastric and/or duodenal ulcer * A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age Exclusion Criteria: * Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification * History of esophageal, gastric or duodenal surgery * Having severe liver disease or chronic renal disease

What they're measuring

Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period

Timeframe: each visit up to 24 weeks

Trial details

NCT IDNCT00542789

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Results submitted2010-02-16

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