check_circleStudy Completed

Hematology

Naproxen Sodium/ASA Platelet Study

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 70 Years

Trial summary

Enrollment Goal
117
Trial Dates
February 2015 - May 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Austin, 78744, United States

Primary Outcome

  • Inhibition of serum Thromboxane B2 (TXB2) on Day 16 at 24 hour post IR ASA 81 mg administration
    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% CI were calculated.
    date_rangeTime Frame:
    At hour 24 on Day 16 post treatment
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    Safety Issue:
    No

Secondary Outcome

  • 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
    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.
    date_rangeTime Frame:
    At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16)
    enhanced_encryption
    Safety Issue:
    No
  • 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
    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.
    date_rangeTime Frame:
    At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19
    enhanced_encryption
    Safety Issue:
    No
  • 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
    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.
    date_rangeTime Frame:
    At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
6