Official Title: “A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, 8 Week Comparative Efficacy and Safety Study of Esomeprazole 20 mg qd Versus Ranitidine 150 mg Bid in Patients With an NSAID-Associated Gastric Ulcer When Daily NSAID is Continued”

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 NSAID therapy.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
• Drug: Ranitidine

Primary Measures

• Assess the efficacy of esomeprazole 20 mg qd through 4 weeks of treatment in these patients

Secondary Measures

• Assess the efficacy of esomeprazole 20 mg qd through 8 weeks of treatment in these patients.
• Evaluate the patient symptoms for up to 8 weeks of treatment in these patients.
• Evaluate the safety and tolerability for up to 8 weeks of treatment in these patients.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Tore Lind, MD Study Director AstraZeneca  

Overall Contact: AstraZeneca China Study Information +86 21 52564555 

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00401752

Study ID Number: D9617L00001

ClinicalTrials.gov Identifier: NCT00401752

Health Authority: China: State Food and Drug Administration