Study Comparing Esomeprazole and Acetylsalicylic Acid (ASA) Combined Together as One Capsule Versus These Medications Taken Separately
NCT ID: NCT00998075
Last Updated: 2010-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
138 participants
INTERVENTIONAL
2009-09-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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1
Esomeprazole 40 mg/ASA 325 mg Fixed Dose Combination Capsule
Esomeprazole/ASA Fixed Combination
Capsule, oral, single dose
2
Esomeprazole Clinical Trial Capsule 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg
Esomeprazole - Nexium
Clinical Trial Capsule or MUPS Tablet, oral, single dose
ASA
Tablet, oral, single dose
3
Esomeprazole MUPS Tablet 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg
Esomeprazole - Nexium
Clinical Trial Capsule or MUPS Tablet, oral, single dose
ASA
Tablet, oral, single dose
Interventions
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Esomeprazole/ASA Fixed Combination
Capsule, oral, single dose
Esomeprazole - Nexium
Clinical Trial Capsule or MUPS Tablet, oral, single dose
ASA
Tablet, oral, single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2
Exclusion Criteria
* Use of any proton pump inhibitors or any bismuth preparations (e.g. Pepto-Bismol®) within 14 days preceding the screening visit
20 Years
50 Years
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Principal Investigators
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TJørgen Næsdal, MD, PhD
Role: STUDY_DIRECTOR
AstraZeneca R&D
Pierre Geoffroy, M.D. C.M., M.S
Role: PRINCIPAL_INVESTIGATOR
Biovail Contract Research (BCR)a Division of Biovail Corporation
Locations
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Research Site
Scarborough Village, Ontario, Canada
Countries
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Other Identifiers
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D961FC00007
Identifier Type: -
Identifier Source: org_study_id