Official Title: “A Comparative Efficacy and Safety of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Placebo for the Prevention of Gastric and Duodenal 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, in patients deemed to be at risk, with either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.

Study Type: Interventional

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

Study Primary Completion Date: February 2003

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 20mg capsule once daily
• Experimental: 2
  • 40mg capsule 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 treatment for the prevention of gastric (and duodenal) ulcers in patients receiving daily NSAID therapy.
  • Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26
    Safety Issue?: No

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 20 mg 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 20 mg qd versus placebo when administered for up to 6 months to patients receiving daily NSAID therapy.
  • Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26
    

Inclusion Criteria:

• 1. No active/current 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: 60 Years

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 October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00629928

Study ID Number: SH-NEN-0014

ClinicalTrials.gov Identifier: NCT00629928

Health Authority: United States: Food and Drug Administration