Naproxen Sodium/ASA Platelet Study
Status: | Completed |
---|---|
Conditions: | Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 4/21/2016 |
Start Date: | February 2015 |
End Date: | May 2015 |
A Randomized, Open Label, Parallel Group Study to Investigate the Effects on Serum Thromboxane by the Addition of Naproxen Sodium to Aspirin Therapy Versus Aspirin Therapy Alone
To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory
effect of a low dose Immediate Release Aspirin (IR ASA) regimen.
effect of a low dose Immediate Release Aspirin (IR ASA) regimen.
Inclusion Criteria:
- Healthy, ambulatory, male and female volunteers between 18 - 70 years of age with a
Body Mass Index (BMI) of approximately 18 to 30 kg/m2, and a total body weight > 50
kg (110 lbs)
- Female subjects of childbearing potential must be using a medically acceptable form
of birth control for at least 1 month prior to screening (3 months on oral
contraceptives), e.g., oral or patch contraceptives, intrauterine device,
Depo-Provera®, or a double barrier and have a negative pregnancy test at Screening
and immediately prior to investigational product administration on Day 1 and Day 6.
Female subjects of non-childbearing potential must be amenorrheic for at least 2
years or had a hysterectomy and/or bilateral oophorectomy
- Results of screening and clinical laboratory tests are within normal range or
considered not clinically significant by the Principal Investigator and the Sponsor
- Be willing and able to participate in all scheduled visits, treatment plan,
laboratory tests and other trial procedures according to the protocol
- Provide a personally signed and dated informed consent indicating that the subject
has been informed of all pertinent aspects of the trial.
Exclusion Criteria:
- History of hypersensitivity or asthma type symptoms with use of aspirin, naproxen
sodium and similar pharmacological agents or components of the products
- Females who are pregnant or lactating
- Any disorder of the Aspirin Triad Syndrome (i.e., asthma, rhinitis or nasal polyps),
or have chronic urticaria
- Eighteen to twenty years old with a viral infection, with or without fever within one
month prior to start of Run-in Period
- History of gastrointestinal bleeding or perforation, related to previous NSAID
therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more
distinct episodes of proven ulceration or bleeding)
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
infectious diseases or malignancies
- Any abnormal laboratory value or physical finding that according to the Investigator
that may interfere with the interpretation of the study results or be indicative of
an underlying disease state
- Have taken any medications including NSAIDs (except acceptable forms of birth
control) within 7 days prior to the start of the Run-in Period or throughout the
study, unless in the opinion of the Investigator and the Sponsor, the medication will
not interfere with the study procedures, data integrity, data interpretation or
compromise the safety of the subject
- Have taken antiplatelet or anticoagulant drugs within 30 days prior to start of the
Run-in Period or during their participation in the study
- Have donated blood or blood components within 30 days prior to study entry
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