Status:
COMPLETED
Mechanisms of Action of Acetaminophen
Lead Sponsor:
University of Pennsylvania
Conditions:
Myocardial Infarction
Arthritis
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This research study investigates whether the ability of aspirin to reduce the risk of heart attacks may be diminished by the administration of acetaminophen. Patients who have heart disease are often ...
Detailed Description
Acetaminophen has antipyretic and moderate analgesic properties, but largely lacks anti-inflammatory activity. While its mechanism of action is not entirely understood, it is probably both an isoform ...
Eligibility Criteria
Inclusion
- Age between 18 - 55
- Subjects recruited for the "non-smoker group" must be in good health as based on medical history, physical examination, vital signs, and laboratory tests.
- Subjects recruited for the "smokers group" will be chronic smokers of at least 4 years duration, but no longer than 20 years duration, who smoke 11-20 cigarettes per day. Smokers must be otherwise healthy as described above.
- Female subjects of child bearing potential must be using a medically acceptable method of contraception (oral contraception, depo-provera injection, intrauterine device, condom with spermicide, diaphragm, cervical cap, progestin implant, abstinence, tubal ligation, oophorectomy, TAH) throughout the entire study period. All female subjects must consent to a urine pregnancy test at screening and just prior to the start of each treatment phase of the study, which must be negative at all time points.
- Subjects must be within 30% of their ideal body weight.
Exclusion
- Female subjects who are pregnant or nursing a child.
- Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening.
- Subjects with any coagulation, bleeding or blood disorders.
- Subjects who are sensitive or allergic to acetaminophen and/or aspirin, as well as any of their components.
- Subjects with documented history of any gastrointestinal disorders, including bleeding ulcers.
- Subjects with any evidence of cancer.
- Subjects with a history of heart disease, including myocardial infarction, angina, coronary artery disease, any evidence of coronary artery stenosis, arrhythmias, heart failure, having had a coronary intervention or significant irregularities in the EKG.
- Subjects with history of peripheral artery disease (claudication, bypass surgery or stent placement in extremity.)
- Subjects with a history of stroke or transitory ischemic attacks.
- Subjects with renal, hepatic, respiratory, endocrine, metabolic, hematopoietic or neurological disorder.
- Subjects with a history of liver disease or abnormal liver function tests (\>2x upper limit normal).
- Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject.
- Subjects who have had a history of drug or alcohol abuse within the last 6 months.
Key Trial Info
Start Date :
June 2 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2012
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00646906
Start Date
June 2 2004
End Date
January 24 2012
Last Update
December 3 2019
Active Locations (1)
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1
Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104