Ulcer Prevention II
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: NSAID Associated Gastric Ulcers
Intervention: Esomeprazole (Drug); Esomeprazole (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Sponsored by: AstraZeneca
Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca
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.
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
Study design: Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
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.
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.
Minimum age: 18 Years.
Maximum age: 60 Years.
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.
1. History of esophageal, gastric or duodenal surgery, except the simple closure of an
- 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.
Locations and Contacts
Starting date: February 2001
Ending date: April 2003
Last updated: February 27, 2008