Ulcer Prevention II
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
2 other identifiers
interventional
800
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2001
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 27, 2008
CompletedFirst Posted
Study publicly available on registry
March 6, 2008
CompletedJanuary 25, 2011
January 1, 2011
2.1 years
February 27, 2008
January 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Assessments at Week 0, Week 4, Week 12, Week 26
Secondary Outcomes (2)
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.
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.
Assessments at Week 0, Week 4, Week 12, Week 26
Study Arms (3)
1
EXPERIMENTAL20mg capsule once daily
2
EXPERIMENTAL40mg capsule daily
3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- No active/current gastric or duodenal ulcer on baseline endoscopy.
- A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
You may not qualify if:
- \. History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer.
- \. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- \. Other criteria, as defined in the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paula Fernstrom
Nexium Global Product Director, AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 27, 2008
First Posted
March 6, 2008
Study Start
February 1, 2001
Primary Completion
March 1, 2003
Study Completion
March 1, 2003
Last Updated
January 25, 2011
Record last verified: 2011-01