drugset
drugset / Trial / NCT02502006

Variability in Response to Non-steroidal Anti-inflammatory Drugs

NCT02502006 ↗

Phase 1 Terminated 16 enrolled University of Pennsylvania National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedCrossoverDouble-blindOther

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.

Timeline

Start
2015-11
Primary completion
2022-09
Completion
2022-09

Outcome

Mixed primary results

Stopped (Enrollment): “Funding was not available to complete enrollment”

registry MEAN Celecoxib: 2869 (Standard Deviation 1357) ng*h/ml NCT02502006 ↗

registry MEAN Naproxen: 115.7 (Standard Deviation 66.8) ng*h/ml NCT02502006 ↗

registry analysis (superiority test); Celecoxib vs Naproxen; p <0.0001; ANOVA NCT02502006 ↗

registry MEAN Celecoxib: 87.86 (Standard Deviation 49.92) ng*h/ml NCT02502006 ↗

registry MEAN Naproxen: 54.71 (Standard Deviation 51.37) ng*h/ml NCT02502006 ↗

registry analysis (superiority test); Celecoxib vs Naproxen; p = 0.0004; ANOVA NCT02502006 ↗

registry MEAN Celecoxib: 8.018 (Standard Deviation 2.488) ng*h/mg creatinine NCT02502006 ↗

registry MEAN Naproxen: 2.907 (Standard Deviation 2.143) ng*h/mg creatinine NCT02502006 ↗

registry analysis (superiority test); Celecoxib vs Naproxen; p = 0.2217; ANOVA NCT02502006 ↗

paper Both nonsteroidal anti-inflammatory drugs inhibited COX-2 activity relative to placebo, but naproxen inhibited COX-2 activity to a greater degree PMID 41459594 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Celecoxib Other / unclassified 100 mg Oral
Subject Celecoxib Other / unclassified 200 mg Oral
Subject Naproxen Small molecule 250 mg Oral
Subject Naproxen Small molecule 500 mg Oral

Indications

No indication recorded.