Trial Outcomes & Findings for Variability in Response to Non-steroidal Anti-inflammatory Drugs (NCT NCT02502006)
NCT ID: NCT02502006
Last Updated: 2023-12-13
Results Overview
COX-1 activity was measured ex vivo using a whole blood assay. Thromboxane A2 serum concentrations were quantified before, and 0.5, 1, 2, 4, 8, and 12 h after treatment and expressed as AUC over the 12 hour dosing interval.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
12 hours
Results posted on
2023-12-13
Participant Flow
Participant milestones
| Measure |
All Study Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
|---|---|
|
Celecoxib
STARTED
|
16
|
|
Celecoxib
COMPLETED
|
16
|
|
Celecoxib
NOT COMPLETED
|
0
|
|
Naproxen
STARTED
|
16
|
|
Naproxen
COMPLETED
|
16
|
|
Naproxen
NOT COMPLETED
|
0
|
|
Placebo
STARTED
|
16
|
|
Placebo
COMPLETED
|
16
|
|
Placebo
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Variability in Response to Non-steroidal Anti-inflammatory Drugs
Baseline characteristics by cohort
| Measure |
Total Enrollment
n=16 Participants
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.
|
|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
|
Body mass index
|
22.6 kg/m^2
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Systolic blood pressure
|
115.3 mm Hg
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Diastolic blood pressure
|
69.8 mm Hg
STANDARD_DEVIATION 9.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 hoursCOX-1 activity was measured ex vivo using a whole blood assay. Thromboxane A2 serum concentrations were quantified before, and 0.5, 1, 2, 4, 8, and 12 h after treatment and expressed as AUC over the 12 hour dosing interval.
Outcome measures
| Measure |
Celecoxib
n=16 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
Naproxen
n=16 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
Placebo
n=16 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
|---|---|---|---|
|
COX-1 Activity ex Vivo
|
2869 ng*h/ml
Standard Deviation 1357
|
115.7 ng*h/ml
Standard Deviation 66.8
|
3135 ng*h/ml
Standard Deviation 1489
|
PRIMARY outcome
Timeframe: 12 hoursCOX-2 activity was assessed ex vivo using a whole blood assay. Prostaglandin E2 concentrations in LPS-treated plasma were quantified before, and 0.5, 1, 2, 4, 8, and 12 h after treatment and expressed as AUC over the 12 hour dosing interval.
Outcome measures
| Measure |
Celecoxib
n=16 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
Naproxen
n=16 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
Placebo
n=16 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
|---|---|---|---|
|
COX-2 Activity ex Vivo
|
87.86 ng*h/ml
Standard Deviation 49.92
|
54.71 ng*h/ml
Standard Deviation 51.37
|
154.1 ng*h/ml
Standard Deviation 83.31
|
PRIMARY outcome
Timeframe: 12 hoursCOX-1 activity was measured in vivo by quantifying the urinary metabolite of thromboxane A2 before, and 1, 2, 4, 8, and 12 h after treatment, normalized to urinary creatinine and expressed as AUC over the 12 hour dosing interval.
Outcome measures
| Measure |
Celecoxib
n=16 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
Naproxen
n=16 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
Placebo
n=16 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
|---|---|---|---|
|
COX-1 Activity in Vivo
|
8.018 ng*h/mg creatinine
Standard Deviation 2.488
|
2.907 ng*h/mg creatinine
Standard Deviation 2.143
|
9.509 ng*h/mg creatinine
Standard Deviation 3.156
|
PRIMARY outcome
Timeframe: 12 hoursCOX-2 activity was measured in vivo by quantifying the urinary metabolite of prostaglandin I2 before, and 1, 2, 4, 8, and 12 h after treatment, normalized to urinary creatinine and expressed as AUC over the 12 hour dosing interval.
Outcome measures
| Measure |
Celecoxib
n=16 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
Naproxen
n=16 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
Placebo
n=16 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
|---|---|---|---|
|
COX-2 Activity in Vivo
|
1.610 ng*h/mg creatinine
Standard Deviation 0.3834
|
1.253 ng*h/mg creatinine
Standard Deviation 0.8699
|
2.413 ng*h/mg creatinine
Standard Deviation 0.8506
|
SECONDARY outcome
Timeframe: 12 hoursPopulation: One participant was excluded from blood pressure analysis due to equipment malfunction and incomplete data
Blood pressure was measured over 12 hours using an automatic ambulatory blood pressure monitor.
Outcome measures
| Measure |
Celecoxib
n=15 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
Naproxen
n=15 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
Placebo
n=15 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
|---|---|---|---|
|
Systolic Blood Pressure
|
123.0 mm Hg
Standard Deviation 10.0
|
127.1 mm Hg
Standard Deviation 10.7
|
124.1 mm Hg
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: 12 hoursPopulation: One participant was excluded from blood pressure analysis due to equipment malfunction and incomplete data
Blood pressure was measured over 12 hours using an automatic ambulatory blood pressure monitor.
Outcome measures
| Measure |
Celecoxib
n=15 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
Naproxen
n=15 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
Placebo
n=15 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
|---|---|---|---|
|
Diastolic Blood Pressure
|
74.8 mm Hg
Standard Deviation 8.5
|
76.6 mm Hg
Standard Deviation 9.3
|
89.7 mm Hg
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: 12 hoursPopulation: One participant was excluding from blood pressure analysis due to equipment malfunction and incomplete data
Blood pressure was measured over 12 hours using an automatic ambulatory blood pressure monitor.
Outcome measures
| Measure |
Celecoxib
n=15 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
Naproxen
n=15 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
Placebo
n=15 Participants
During each treatment phase, subjects received celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects were 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.
|
|---|---|---|---|
|
Mean Arterial Pressure
|
90.4 mm Hg
Standard Deviation 8.4
|
92.9 mm Hg
Standard Deviation 8.9
|
89.7 mm Hg
Standard Deviation 8.7
|
Adverse Events
Celecoxib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Naproxen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Katherine N. Theken, PharmD, PhD
University of Pennsylvania
Phone: 2158987470
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place