Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 86 for:    ASPIRIN AND thromboxane

Naproxen Sodium/ASA Platelet Study (Kontakt)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02229461
Recruitment Status : Completed
First Posted : September 1, 2014
Results First Posted : June 10, 2016
Last Update Posted : July 15, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE July 31, 2014
First Posted Date  ICMJE September 1, 2014
Results First Submitted Date  ICMJE May 4, 2016
Results First Posted Date  ICMJE June 10, 2016
Last Update Posted Date July 15, 2016
Study Start Date  ICMJE February 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration [ Time Frame: At hour 24 on Day 16 post treatment ]
Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
Serum TXB2 inhibition [ Time Frame: Day 1 and Day 16, hour 24 ]
Serum TXB2 inhibition is calculated using the percentage of reduction in serum TXB2 levels
Change History Complete list of historical versions of study NCT02229461 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
  • Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration [ Time Frame: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16) ]
    Inhibition of serum TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.
  • Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration [ Time Frame: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 ]
    Inhibition of AA-induced platelet aggregation at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. The platelet aggregation change-from-baseline scores range broadly in large part due to inclusion of participants with low baseline platelet aggregation scores.
  • Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration [ Time Frame: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 ]
    Inhibition of plasma TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
  • Inhibition of serum TXB2 [ Time Frame: Baseline day 1 and different time points at days 7, 16, 17, 19 ]
    Serum TXB2 inhibition is calculated using the percentage of reduction in serum TXB2 levels
  • Inhibition of platelet aggregation in response to Arachidonic Acid (AA) [ Time Frame: Baseline day 1 and different time points at days 7, 16, 17, 19 ]
    measured by light transmission aggregometry Light Transmission Aggregometry(LTA)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Naproxen Sodium/ASA Platelet Study
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hematology
Intervention  ICMJE
  • Drug: Naproxen Sodium (Aleve, BAY117031)
    Naproxen sodium 220 mg qd or bid
  • Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
    ASA 81 mg qd
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Drug: Naproxen Sodium (Aleve, BAY117031)
    • Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
  • Experimental: 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.
    Interventions:
    • Drug: Naproxen Sodium (Aleve, BAY117031)
    • Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
  • Experimental: 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.
    Interventions:
    • Drug: Naproxen Sodium (Aleve, BAY117031)
    • Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
  • Active Comparator: 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.
    Intervention: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
  • Experimental: 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.
    Interventions:
    • Drug: Naproxen Sodium (Aleve, BAY117031)
    • Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
  • Experimental: 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.
    Interventions:
    • Drug: Naproxen Sodium (Aleve, BAY117031)
    • Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2015)
117
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2014)
102
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02229461
Other Study ID Numbers  ICMJE 15525
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP