HealthyEarly Phase 1NCT03590821
Timed Aspirin Chronobiome Study
A Early Phase 1 study testing Aspirin 81 mg and Celecoxib 200mg capsule in people with Healthy, run by University of Pennsylvania at 1 site in United States.
Trial summary
To determine whether timed administration of aspirin ameliorates the effects of celecoxib on blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aspirin 81 mg and Celecoxib 200mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2027to Nov 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women greater than 18 years of age
- Subjects must be in good health based on medical history, physical examination, vital signs, and laboratory tests. In order to ensure sufficient enrollment of subjects in the higher age groups, volunteers with the following conditions may participate in the study:
- Adequately controlled hypertension, with diastolic blood pressure ≤100 mmHg at screening.
- Total cholesterol of ≤270 mg/dL
- Body mass index (BMI) between 18 and 30 kg/m2.
- Has not used tobacco products, including smoking cessation nicotine-containing products (e.g., nicotine patch, nicotine gum), for at least the 3 months prior to screening.
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- Female subjects of child bearing potential must be using a medically acceptable method of contraception (oral contraception, Depo-Provera injection, IUD, condom with spermicide, diaphragm, cervical cap, progestin implant, abstinence, tubal ligation, oophorectomy, TAH) throughout the entire study period. All female subjects must consent to a serum and urine pregnancy test at screening and close-out and a urine pregnancy test just prior to the start of each treatment phase of the study, which must be negative at all time points.
- All subjects must consent to a urine drug and nicotine test at screening. Results must be negative. A positive result will be reported to the subject.
- Does not consume more than 1 alcoholic beverage per day on average.
- Able and willing to refrain from alcohol use within 48 hours prior to the first dose of study drug and during the study period until the final study visit.
- Able to understand and comply with study procedures.
- Able and willing to provide written informed consent prior to any study procedures being performed.
Who cannot join
- Female subjects who are pregnant or nursing a child.
- Subjects who have received an investigational drug or used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening.
- Subjects with any coagulation, bleeding or blood disorders.
- Subjects who are sensitive or allergic to celecoxib (Celebrex) or aspirin or their components.
- Subjects who are sensitive or allergic to aspirin or other NSAIDs.
- Subjects with documented history of any gastrointestinal disorders, including bleeding ulcers.
Show all 22Show fewer
- History of significant cardiovascular disease (including stroke or TIA), renal, hepatic, respiratory (except infections which longer > 6 months prior to screening), immune, endocrine, hematopoietic disorder or neurological disorders.
- History of cancer within the last 5 years (except for cutaneous basal cell or squamous cell cancer resolved by excision, or carcinoma in situ of the cervix adequately treated).
- Has taken any prescription medication other than hormone replacement therapy (including males taking testosterone as a hormone replacement to treat a documented low testosterone level), thyroid replacement hormones, anti-hyperlipidemic agents, or anti-hypertensive medications. Individuals taking other/additional chronic stable medications can be considered on a case-by-case basis for inclusion in the study if agreed upon by judgment of the investigators.
- Has taken the following NSAID or antisecretory agents within 2 weeks prior to study drug administration:
- Nonsteroidal anti-inflammatory drugs (NSAIDs) including acetaminophen or other medications for pain, including aspirin or aspirin-containing products
- Proton pump inhibitors, including Prilosec®, Prevacid®, Aciphex®, Protonix®, or Nexium® (antacid medications, including OTC products, are not permitted within 24 hours of dosing)
- H2 blockers, including Tagamet®, Zantac®, Axid®, or Pepcid®
- Has ever taken the following anti-platelet or anti-coagulant agents:
- Any anti-platelet agent, including Aggrenox®, Brilinta®, Plavix®, Ticlid®, Pletal®, ReoPro®, Integrilin®, Aggrastat®, Persantine®, or Effient®
- Any anti-coagulant including Arixtra®, Coumadin®, acenocoumarol, Lovenox®, phenprocoumon, phenindione, heparin, Exanta®, Pradaxa®, argatroban, lepirudin, hirudin, bivalirudin, or Xarelto®
- Used dietary or herbal supplements containing salicylates, Vitamin E, fish oil, or any other herbal supplements, within 14 days of study drug administration.
- Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject.
- Subjects who have had a history of drug or alcohol abuse within the last 6 months.
- Subjects who are unwilling to provide a blood sample for genetic analyses and creation of a lymphoblastoid cell line.
- Any contraindication listed below in the separate paragraph "Contraindications for the use of CorTemp® Disposable Temperature Sensors".
- Volunteers enrolled in the sub-study who do not own a smartphone.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania
Philadelphia, Pennsylvania, 19104
LaVenia Banas, RN, 215-573-1862, banas@pennmedicine.upenn.edu
Carsten Skarke, MD, 215-573-0673, cskarke@pennmedicine.upenn.edu
About this study
Official title: Modulating Celecoxib Induced Blood Pressure Changes by Timed Administration of Aspirin and the Human Chronobiome
To determine whether timed administration of aspirin ameliorates the effects of celecoxib on blood pressure.
Read the detailed description
Non-steroidal anti-inflammatory drugs (NSAIDs) are a commonly used and effective treatment of inflammatory pain. However, all NSAID have the potential to raise blood pressure (BP), cause the development of new hypertension or exacerbate preexisting hypertension. Strategies to mitigating that risk short of withholding the analgesic are missing. In this proposal, the investigators wish to determine whether timed administration of low dose aspirin can be developed as a low cost intervention with well-defined risk profile to mitigate the blood pressure raise associated with the COX-2 selective NSAID celecoxib. Low dose aspirin administered in the evening, but not in the morning, normalizes the mean arterial BP in clinical studies of prehypertension, mild essential hypertension and preeclampsia. The investigators will address this in an interventional study in healthy volunteers who displayed a blood pressure increase during celecoxib treatment in an ongoing study. Since individuals have varying chronotypes and work/social rhythms, parameter measuring day/night patterns, the chronobiome, will be part of this study.
- Conditions
- Healthy
- Being tested
- Aspirin 81 mg, Celecoxib 200mg capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 81 mgDrug
timed administration of aspirin in the evening
Celecoxib 200mg capsuleDrug
daily administration of celecoxib
| Study group | Role | What they receive |
|---|---|---|
| Aspirin 81 mg/Placebo | Experimental | 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. Receives: Drug: Aspirin 81 mg; Drug: Celecoxib 200mg capsule |
| Celecoxib 200mg capsule | Experimental | Participants will receive celecoxib in Phase 1 and Phase 2 over 7 days. This is open, meaning participant and investigator will recognize celecoxib capsules. Receives: Drug: Aspirin 81 mg; Drug: Celecoxib 200mg capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure [mmHg]
Ambulatory blood pressure measurements
Measured: 24-48 hours
Secondary outcomes (1)
Mean arterial pressure (MAP)
MAP calculated as (2 x diastolic blood pressure [mmHg]) + systolic blood pressure [mmHg]) /3
Measured: 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study startDec 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective study design, double-blinded and randomized by order for acetylsalicylic acid versus placebo, open for celecoxib. In a prospective study each individual will undergo two treatment periods randomized by order (separated by 3 weeks of washout). In one period, placebo (matching aspirin for double-blinding) will be administered in the evening for 14 days. In the other period, aspirin (81 mg QD) will be administered in the evening for 14 days. Drug intake will be timed to occur within 1-2 hours prior to falling asleep. Celecoxib (200 mg BID) will be added openly for the final 7 days during each treatment period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Skarke, MD, University of Pennsylvania
- Investigators
- Carsten Skarke, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590821
- Sponsor's protocol ID
- 829532
- Status last verified
- May 2026
- First submitted
- 3 May 2018
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to be determined
Publications
Skarke C, Lahens NF, Rhoades SD, Campbell A, Bittinger K, Bailey A, Hoffmann C, Olson RS, Chen L, Yang G, Price TS, Moore JH, Bushman FD, Greene CS, Grant GR, Weljie AM, FitzGerald GA. A Pilot Characterization of the Human Chronobiome. Sci Rep. 2017 Dec 7;7(1):17141. doi: 10.1038/s41598-017-17362-6.
PubMed 29215023
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Celecoxib Induced Blood Pressure Changes by Timed Administration of Aspirin and the Human Chronobiome
- ClinicalTrials.gov ID
- NCT03590821
- Acronym / sponsor ID
- 829532
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Dec 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether timed administration of aspirin ameliorates the effects of celecoxib on blood pressure.
Detailed description
Non-steroidal anti-inflammatory drugs (NSAIDs) are a commonly used and effective treatment of inflammatory pain. However, all NSAID have the potential to raise blood pressure (BP), cause the development of new hypertension or exacerbate preexisting hypertension. Strategies to mitigating that risk short of withholding the analgesic are missing. In this proposal, the investigators wish to determine whether timed administration of low dose aspirin can be developed as a low cost intervention with well-defined risk profile to mitigate the blood pressure raise associated with the COX-2 selective NSAID celecoxib. Low dose aspirin administered in the evening, but not in the morning, normalizes the mean arterial BP in clinical studies of prehypertension, mild essential hypertension and preeclampsia. The investigators will address this in an interventional study in healthy volunteers who displayed a blood pressure increase during celecoxib treatment in an ongoing study. Since individuals have varying chronotypes and work/social rhythms, parameter measuring day/night patterns, the chronobiome, will be part of this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective study design, double-blinded and randomized by order for acetylsalicylic acid versus placebo, open for celecoxib. In a prospective study each individual will undergo two treatment periods randomized by order (separated by 3 weeks of washout). In one period, placebo (matching aspirin for double-blinding) will be administered in the evening for 14 days. In the other period, aspirin (81 mg QD) will be administered in the evening for 14 days. Drug intake will be timed to occur within 1-2 hours prior to falling asleep. Celecoxib (200 mg BID) will be added openly for the final 7 days during each treatment period.
| Arm | Type | Receives |
|---|---|---|
| Aspirin 81 mg/Placebo | Experimental | Drug: Aspirin 81 mg, Drug: Celecoxib 200mg capsuleParticipants 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. |
| Celecoxib 200mg capsule | Experimental | Drug: Aspirin 81 mg, Drug: Celecoxib 200mg capsuleParticipants will receive celecoxib in Phase 1 and Phase 2 over 7 days. This is open, meaning participant and investigator will recognize celecoxib capsules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men and women greater than 18 years of age
- Subjects must be in good health based on medical history, physical examination, vital signs, and laboratory tests. In order to ensure sufficient enrollment of subjects in the higher age groups, volunteers with the following conditions may participate in the study:
- Body mass index (BMI) between 18 and 30 kg/m2.
- Has not used tobacco products, including smoking cessation nicotine-containing products (e.g., nicotine patch, nicotine gum), for at least the 3 months prior to screening.
- Female subjects of child bearing potential must be using a medically acceptable method of contraception (oral contraception, Depo-Provera injection, IUD, condom with spermicide, diaphragm, cervical cap, progestin implant, abstinence, tubal ligation, oophorectomy, TAH) throughout the entire study period. All female subjects must consent to a serum and urine pregnancy test at screening and close-out and a urine pregnancy test just prior to the start of each treatment phase of the study, which must be negative at all time points.
Key exclusion criteria (22 listed)
- Female subjects who are pregnant or nursing a child.
- Subjects who have received an investigational drug or used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening.
- Subjects with any coagulation, bleeding or blood disorders.
- Subjects who are sensitive or allergic to celecoxib (Celebrex) or aspirin or their components.
- Subjects who are sensitive or allergic to aspirin or other NSAIDs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 81 mgtimed administration of aspirin in the evening | Drug | Aspirin 81 mg/Placebo, Celecoxib 200mg capsule |
| Celecoxib 200mg capsuledaily administration of celecoxib | Drug | Aspirin 81 mg/Placebo, Celecoxib 200mg capsule |
Primary outcome
Blood pressure [mmHg]
Time frame: 24-48 hours
Ambulatory blood pressure measurements
1 secondary outcome
Mean arterial pressure (MAP)
Time frame: 24-48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 29215023Skarke C, Lahens NF, Rhoades SD, Campbell A, Bittinger K, Bailey A, Hoffmann C, Olson RS, Chen L, Yang G, Price TS, Moore JH, Bushman FD, Greene CS, Grant GR, Weljie AM, FitzGerald GA. A Pilot Characterization of the Human Chronobiome. Sci Rep. 2017 Dec 7;7(1):17141. doi: 10.1038/s41598-017-17362-6.
- Individual participant dataSharing planned: Undecided. to be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carsten Skarke, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aspirin 81 mg and Celecoxib 200mg capsule in people with Healthy, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LaVenia Banas, CRN (215-573-1862, banas@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure [mmHg] (time frame: 24-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03590821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.