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
EARLY_PHASE1
268 participants
INTERVENTIONAL
2019-10-08
2022-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Placebo
Single dose of a 500mg placebo tablet.
Placebo
Single 500mg placebo capsule.
Aspirin 500MG
Single dose of a 500 mg aspirin tablet.
Aspirin 500 MG
Single 500mg aspirin capsule.
Interventions
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Aspirin 500 MG
Single 500mg aspirin capsule.
Placebo
Single 500mg placebo capsule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
Participants will also be excluded for the following medical reasons:
1. Having an allergy to aspirin, other salicylates, or any other pain reliever/fever reducer.
2. Having or recovering from a viral infection such as the chicken pox or flu.
3. Having taken aspirin or another NSAID drug (aspirin, ibuprofen, naproxen, or others) within the last 8 hours or plan to take aspirin or another NSAID drug in the 8 hours after the end of the study.
4. Having more than three drinks of alcohol in the 8 hours after completion of the study.
5. Having asthma, hay fever, nasal polyps, or chronic respiratory disease.
6. Impaired liver/kidney or impaired cardiovascular circulation (renal vascular disease, congestive heart failure, volume depletion, major surgery, sepsis or major hemorrhagic events)
7. Active or severe liver or kidney disease.
8. An ulcer, history of ulcers or are prone to bleeding.
9. A history of blood clotting defects.
10. Severe anemia.
11. Taking any of the following drugs: A blood thinning anticoagulant (e.g. warfarin), Digoxin, An Angiotensin Converting Enzyme (ACE) Inhibitor, Methotrexate, An oral glucocorticoid (e.g. hydrocortisone),Valproic Acid, A Selective Serotonin Reuptake Inhibitor (SSRI; e.g. Prozac; Zoloft)
12. Have had stomach ulcers or bleeding problems.
13. Have stomach problems such as heartburn, upset stomach, or stomach pain that does not go away or reoccurs.
14. Surgery in the last week or will have a surgery in the next week.
15. High blood pressure.
16. Diabetes, gout, or arthritis.
17. Low uric acid or Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
18 Years
MALE
Yes
Sponsors
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Ohio State University
OTHER
Responsible Party
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Baldwin Way
Associate Professor
Locations
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Psychology Building
Columbus, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019H0262
Identifier Type: -
Identifier Source: org_study_id
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