Prevention of Gastric Ulcers
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 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Professor Chris Hawkey, Principal Investigator, Affiliation: Queens Medical Centre
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca
Summary
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.
Clinical Details
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
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 the treatment for the prevention of gastric (and/or duodenal) ulcers in patients receiving daily NSAID therapy and being at risk
Secondary outcome: 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.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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: March 2001
Ending date: February 2003
Last updated: March 5, 2008
|
