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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Gastric Ulcer

Treatments

Drug: Esomeprazole

Drug: Ranitidine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00401752

D9617L00001

Details and patient eligibility

About

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.

Enrollment

397 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.