CompletedPhase 3

Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer

China397 participantsStarted 2006-03

Plain-language summary

The purpose of this study is to assess the efficacy of esomeprazole 20 mg dosed once daily and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of gastric ulcers in patients receiving daily non-steroidal anti-inflammatory drug (NSAID)therapy.

Who can participate

Age range18 Years – 70 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: * Signed informed consent. * A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 2 months. * Daily NSAID dose and type must have been stable for at least 2 weeks prior to the baseline endoscopy;orally; 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.

What they're measuring

The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy.

Timeframe: 4 weeks

Trial details

NCT IDNCT00401752

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Results submitted2009-11-12

View on ClinicalTrials.gov More Gastric Ulcer trials