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Non-Steroidal Anti-Inflammatory Drug

Celecoxib for Healthy Subjects

Phase 1
Waitlist Available
Led By Carsten Skarke, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult men and women greater than 18 years of age who are non-smokers and in good health based on medical history, physical examination, vital signs, and laboratory tests. Volunteers with adequately controlled hypertension and hyperlipidemia (total cholesterol of ≤270 mg/dL) may participate in the study.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 hours
Awards & highlights

Study Summary

This research study will evaluate inter-individual variability in the response to the non-steroidal anti-inflammatory drugs (NSAIDs), celecoxib and naproxen, among healthy adults. It will also investigate what factors, like age, sex, or genetic background, cause this variability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
COX-1 Activity ex Vivo
COX-1 Activity in Vivo
COX-2 Activity ex Vivo
+1 more
Secondary outcome measures
Diastolic Blood Pressure
Mean Arterial Pressure
Systolic Blood Pressure

Side effects data

From 2010 Phase 2 trial • 255 Patients • NCT01062113
5%
Beta 2 microglobulin increased
3%
Beta-N-acetyl-D-glucosaminidase increased
3%
Blood bilirubin increased
2%
Eczema
1%
White blood cell count increased
1%
Blood urine present
1%
Hypoaesthesia facial
1%
Rash
1%
Post procedural haemorrhage
1%
Blood creatine phosphokinase increased
1%
Blood phosphorus decreased
1%
Urobilin urine present
1%
Presyncope
1%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Initial Dose Celecoxib 400 mg
Additional Dose Placebo
Additional Dose Celecoxib 200 mg

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low doseExperimental Treatment3 Interventions
During each treatment phase, subjects will receive celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects will be instructed to take the study medications twice a day (at approximately 8 AM and 8 PM) on an empty stomach with a full glass of water.
Group II: High DoseExperimental Treatment3 Interventions
During each treatment phase, subjects will receive celecoxib (200 mg by mouth twice daily), naproxen (500 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects will be instructed to take the study medications twice a day (at approximately 8 AM and 8 PM) on an empty stomach with a full glass of water.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naproxen
2019
Completed Phase 4
~31530
Celecoxib
2019
Completed Phase 4
~1740
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,072 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,310,619 Total Patients Enrolled
Carsten Skarke, MDPrincipal InvestigatorUniversity of Pennsylvania, Institute for Translational Medicine and Therapeutics
7 Previous Clinical Trials
236 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Variability in Response to Non-steroidal Anti-inflammatory Drugs
2015. "Variability in Response to Non-steroidal Anti-inflammatory Drugs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02502006.
~2 spots leftby Apr 2025
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