Timed Aspirin Chronobiome Study

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT03590821
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Aspirin 81 mg — DRUG
    timed administration of aspirin in the evening
  • Celecoxib 200mg capsule — DRUG
    daily administration of celecoxib

Study Details

To determine whether timed administration of aspirin ameliorates the effects of celecoxib on blood pressure.

Key Dates

Start date
Dec 31, 2027
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Aspirin 81 mg/Placebo
    Participants will receive aspirin in Phase 1 followed by matched placebo in Phase 2, or vice versa, over 14 days. The order will be randomized and aspirin/placebo will be double-blinded.
  • Experimental: Celecoxib 200mg capsule
    Participants will receive celecoxib in Phase 1 and Phase 2 over 7 days. This is open, meaning participant and investigator will recognize celecoxib capsules.

Primary Outcome Measure

Blood pressure [mmHg] [ Time Frame: 24-48 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Institute for Translational Medicine and Therapeutics (ITMAT), University of PennsylvaniaPhiladelphiaPennsylvania19104
LaVenia Banas, RN
[email protected]
215-573-1862
Carsten Skarke, MD
[email protected]
215-573-0673
Carsten Skarke, MD (PRINCIPAL_INVESTIGATOR)
Tilo Grosser, MD (PRINCIPAL_INVESTIGATOR)
Katherine Theken, PhD (PRINCIPAL_INVESTIGATOR)
Garret FitzGerald, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania· Philadelphia, PA

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