Official Title: “A Comparative Efficacy and Safety Study of Nexium (Esomeprazole Magnesium) Delayed-Release Capsules (40mg qd and 20mg qd) Versus Placebo for the Prevention of Gastric Ulcers Associated With Daily NSAID Use in Patients at Risk”

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention 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; versus placebo; in patients at risk.

Study Type: Interventional

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

Study Primary Completion Date: December 2002

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
  • 20mg oral daily
• Drug: Esomeprazole
  • 40mg oral daily
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 20mg oral daily
• Experimental: 2
  • 40mg oral daily
• Placebo Comparator: 3

Primary Measures

• To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of the treatment for the prevention of gastric (and/or duodenal) ulcers in patients receiving daily NSAID therapy and being at risk
  • Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26
    

Secondary Measures

• Investigator-assessed symptoms, defined as control of NSAID-associated GI symptoms for up to 6 months of treatment with esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo in patients receiving daily NSAID therapy.
  • Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26
    
• Safety and tolerability of esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo for up to 6 months of treatment in patients receiving daily NSAID therapy
  • Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26
    

Inclusion Criteria:

• 1. No gastric or duodenal ulcer on baseline endoscopy.
• 2. A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
• 3. Other inclusion criteria, as defined in the protocol.

Exclusion Criteria:

• 1. History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer.
• 2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
• 3. Other criteria, as defined 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

Professor Chris Hawkey Principal Investigator Queens Medical Centre  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00629512

Study ID Number: SH-NEN-0013

ClinicalTrials.gov Identifier: NCT00629512

Health Authority: United States: Food and Drug Administration