Changes in mRNA Expression Following Exposure to Naproxen
NCT ID: NCT01090596
Last Updated: 2010-03-22
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
NA
48 participants
INTERVENTIONAL
2007-04-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
DOUBLE
Study Groups
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Naproxen-Treated
Naproxen
500mg naproxen, twice daily for 7 days
placebo
Placebo
1 tab,twice a day for a seven days
Interventions
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Naproxen
500mg naproxen, twice daily for 7 days
Placebo
1 tab,twice a day for a seven days
Eligibility Criteria
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Inclusion Criteria
* Written informed consent prior to undergoing any study procedures
* A physical examination which reveals no clinically significant abnormalities
* Female subjects of childbearing potential must be taking an acceptable form of contraceptive
Exclusion Criteria
* Any GDU or \>5 gastroduodenal erosions at baseline endoscopy
* CXB, CPG, ASA, or NS-NSAID use within the prior 2 weeks
* Previous gastrointestinal ulcer
* Hypersensitivity or allergy to NSAIDs, ASA, CPG, CXB or other contraindication to taking treatments
* Baseline complaints of abdominal pain, nausea, and/or cramping
* Any acid blocking medication including antacids, H-2 receptor blocker within the prior 2 weeks, or PPI use within the prior 30 days
* Corticosteroids use within the prior 60 days
* Any documented bleeding tendency
* Has taken warfarin within the prior 60 days
* Three or greater alcoholic beverages daily
* History of cerebro-vascular event
18 Years
75 Years
ALL
Yes
Sponsors
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Research Associates of New York, LLP
OTHER
Responsible Party
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Research Associates of New York
Principal Investigators
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James Aisenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Research Associates of New York
Other Identifiers
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ResearchANY
Identifier Type: -
Identifier Source: org_study_id
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