Back to resultsPrevention of Gastric Ulcers
Primary Purpose
NSAID Associated Gastric Ulcers
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Esomeprazole
Esomeprazole
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for NSAID Associated Gastric Ulcers focused on measuring NSAID, Nexium, esomeprazole, Gastric Ulcers
Eligibility Criteria
Inclusion Criteria:
- No gastric or duodenal ulcer on baseline endoscopy.
- A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
- Other inclusion criteria, as defined in the protocol.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
20mg oral daily
40mg oral daily
Outcomes
Primary Outcome 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
Secondary Outcome 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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00629512
Brief Title
Prevention of Gastric Ulcers
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSAID Associated Gastric Ulcers
Keywords
NSAID, Nexium, esomeprazole, Gastric Ulcers
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
504 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
20mg oral daily
Arm Title
2
Arm Type
Experimental
Arm Description
40mg oral daily
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
20mg oral daily
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
40mg oral daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
No gastric or duodenal ulcer on baseline endoscopy.
A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
Other inclusion criteria, as defined in the protocol.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Chris Hawkey
Organizational Affiliation
Queens Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paula Fernstrom
Organizational Affiliation
Nexium Global Product Director, AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Prevention of Gastric Ulcers
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