Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily for subjects in the US only.

Study Type: Interventional

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

Study Primary Completion Date: March 2003

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
  • 20mg oral daily
• Drug: Ranitidine
  • 150mg oral twice daily
• Drug: Esomeprazole
  • 40mg oral tablet daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 20mg Oral tablet daily
• Experimental: 2
  • 40mg Oral tablet daily
• Active Comparator: 3
  • 150mg oral twice daily

Primary Measures

• The proportion of patients with no gastric ulcers after 8 weeks of treatment.
  • Time Frame: Esophagogastroduodenscopy (EGD) assessments at baseline, week 4, week 8, and efficacy evaluations at each visit including endoscopic evaluation for the presence of ulcers and erosions.
    

Secondary Measures

• The patient and investigator symptoms, defined as control of NSAID-associated GI symptoms up to 8 weeks of treatment with esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily N
  • Time Frame: Assessments at Week 0, Week 4 and Week 8
    
• To look at any side effects of esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily NSAID therapy.
  • Time Frame: Assessments at Week 0, Week 4 and Week 8
    

Inclusion Criteria:

• A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
• A gastric ulcer >= 5mm in diameter, but no ulcer >25 mm at its greatest diameter, at the baseline endoscopy.
• Other key inclusion criteria, as specified in the protocol.

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.
• Many other conditions and criteria, as specified in the protocol.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Paula Fernstrom Study Director Nexium Global Product Director, AstraZeneca  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00633412

Study ID Number: SH-NEN-0005

ClinicalTrials.gov Identifier: NCT00633412

Health Authority: United States: Food and Drug Administration