Naproxen Sodium/ASA Platelet Study

Pain Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229461
• Other study ID #: 15525
• Status: Completed
• Phase: Phase 1
• First received: July 31, 2014
• Last updated: February 23, 2016
• Start date: February 2015
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory effect of a low dose Immediate Release Aspirin (IR ASA) regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Aleve(Naproxen Sodium,BAY117031)
Naproxen sodium 220 mg qd
• Aspirin (Acetylsalicylic Acid, BAYE4465)
ASA 81 mg qd

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum TXB2 inhibition	Serum TXB2 inhibition is calculated using the percentage of reduction in serum TXB2 levels	Day 1 and Day 16, hour 24	No
Secondary	Inhibition of serum TXB2	Serum TXB2 inhibition is calculated using the percentage of reduction in serum TXB2 levels	Baseline day 1 and different time points at days 7, 16, 17, 19	No
Secondary	Inhibition of platelet aggregation in response to Arachidonic Acid (AA)	measured by light transmission aggregometry Light Transmission Aggregometry(LTA)	Baseline day 1 and different time points at days 7, 16, 17, 19	No

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