Naproxen Sodium/ASA Platelet Study

NCT ID: NCT02229461

Last Updated: 2016-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-05-31

Brief 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.

Conditions

Hematology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IR ASA co-administered with naproxen sodium

Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.

Group Type: EXPERIMENTAL

Naproxen Sodium (Aleve, BAY117031)

Intervention Type: DRUG

Naproxen sodium 220 mg qd or bid

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type: DRUG

ASA 81 mg qd

IR ASA 30 min after naproxen sodium

Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.

Group Type: EXPERIMENTAL

Naproxen Sodium (Aleve, BAY117031)

Intervention Type: DRUG

Naproxen sodium 220 mg qd or bid

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type: DRUG

ASA 81 mg qd

IR ASA 8 hours after naproxen sodium

Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.

Group Type: EXPERIMENTAL

Naproxen Sodium (Aleve, BAY117031)

Intervention Type: DRUG

Naproxen sodium 220 mg qd or bid

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type: DRUG

ASA 81 mg qd

IR ASA only

Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.

Group Type: ACTIVE_COMPARATOR

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type: DRUG

ASA 81 mg qd

IR ASA 30 min before naproxen sodium

Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.

Group Type: EXPERIMENTAL

Naproxen Sodium (Aleve, BAY117031)

Intervention Type: DRUG

Naproxen sodium 220 mg qd or bid

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type: DRUG

ASA 81 mg qd

IR ASA 30 min after first dose of naproxen sodium bid

Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.

Group Type: EXPERIMENTAL

Naproxen Sodium (Aleve, BAY117031)

Intervention Type: DRUG

Naproxen sodium 220 mg qd or bid

Acetylsalicylic Acid (Aspirin, BAYE4465)

Intervention Type: DRUG

ASA 81 mg qd

Interventions

Naproxen Sodium (Aleve, BAY117031)

Naproxen sodium 220 mg qd or bid

Intervention Type: DRUG

Acetylsalicylic Acid (Aspirin, BAYE4465)

ASA 81 mg qd

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Austin, Texas, United States

Countries

United States

References

Gurbel PA, Bliden KP, Zhu J, Troullos E, Centofanti R, Jarvis S, Venkataraman P, Tantry US. Thromboxane inhibition during concurrent therapy with low-dose aspirin and over-the-counter naproxen sodium. J Thromb Thrombolysis. 2018 Jan;45(1):18-26. doi: 10.1007/s11239-017-1593-y.

Reference Type: DERIVED

PMID: 29198079 (View on PubMed)

Other Identifiers

15525

Identifier Type: -

Identifier Source: org_study_id