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NCT02413203 · ClinicalTrials.gov registry record · NA
Lipidomics Screening of Celecoxib in ex Vivo Human Whole Blood Assay - Part B
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT02413203: Completed NA study, sponsored by University of Pennsylvania.
NCT02413203 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02413203, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
Cardiovascular complications of NSAIDs, selective for inhibition of COX-2, stimulated interest in microsomal prostaglandin E synthase-1 (mPGES-1) as an alternative drug target. Global deletion of mPGES-1 in mice suppresses prostaglandin (PG) E2 and augments PGI2 by PGH2 substrate rediversion. Unlike COX-2 inhibition or gene deletion, mPGES-1 deletion does not cause a predisposition to thrombogenesis and hypertension. However, cell-specific deletion of mPGES-1 reveals that the predominant substrate rediversion product among the prostaglandins varies by cell type, complicating drug development. The research team has developed an ultra performance liquid chromatography/ tandem mass spectrometry (UPLC-MS/MS) technique that allows the quantification of a wide range of lipids beyond the prostaglandin pathway (leukotrienes, anandamide and the 2-arachidonylglycerol cascades). This study is designed to examine different pathway interventions from the arachidonic acid cascade by anti-inflammatory compounds (with a focus on mPGES-1 inhibition) in whole human blood in vitro (Part A) and ex vivo (Part B). In Part B, healthy volunteers will be asked to take a single, therapeutic dose of celecoxib and blood and urine samples will be collected before and after drug administration. Collected blood will be stimulated ex vivo, and lipids and their metabolites will be measured in blood and urine, respectively. The investigators expect that lipid profile from ex vivo hWBA done on celecoxib-treated subjects will recapitulate findings from the in vitro hWBA received with celecoxib-treated human blood (Part A).
Primary Outcome
PGE2 in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma PGE2 was normalized to sample volume (ng/ml) and expressed as a percentage of subject's pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents PGE2 concentration in ng/ml.
Interventions
- DRUG Placebo
- DRUG Celecoxib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-03 |
| Est. Completion | 2015-11 |
| Phase | NA |
What the finished NCT02413203 record still lists
NCT02413203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02413203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02413203 about?
NCT02413203 is a clinical study titled "Lipidomics Screening of Celecoxib in ex Vivo Human Whole Blood Assay - Part B". Cardiovascular complications of NSAIDs, selective for inhibition of COX-2, stimulated interest in microsomal prostaglandin E synthase-1 (mPGES-1) as an alternative drug target. Global deletion of mPGES-1 in mice suppresses prostaglandin (PG) E2 and augments PGI2 by PGH2 substrate rediversion. Unlike...
What is the current status of trial NCT02413203?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2015-03. Estimated completion is 2015-11.
What interventions are being tested in trial NCT02413203?
The interventions under investigation include: Placebo (DRUG), Celecoxib (DRUG).
Who is sponsoring clinical trial NCT02413203?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02413203's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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