Official Title: “A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued”

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: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.

Study Type: Interventional

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

Study Primary Completion Date: April 2003

Intervention(s) in this Clinical Trial

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

• To assess the safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers.

Secondary Measures

• Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.
  • Time Frame: Assessments at week 0, week 4 and week 8
    
• Safety and tolerability of the treatments for 8 weeks of treatment.
  • Time Frame: Assessments at week 0, week 4 and week 8
    

Inclusion Criteria:

• 1. A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
• 2. Other key inclusion criteria, as specified in the protocol.

Exclusion Criteria:

• 1. History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
• 2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
• 3. 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 September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00633672

Study ID Number: SH-NEN-0006

ClinicalTrials.gov Identifier: NCT00633672

Health Authority: United States: Food and Drug Administration