CompletedPhase 3

Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer

Japan395 participantsStarted 2007-10

Plain-language summary

The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.

Who can participate

Age range20 Years

SexALL

See this in plain English?

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

Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period

Timeframe: up to 52 weeks

Trial details

NCT IDNCT00595517

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-09

Results submitted2010-08-04

View on ClinicalTrials.gov More Gastric Ulcer trials