Lipidomics Screening of Celecoxib in ex Vivo Human Whole Blood Assay - Part B
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ClinicalTrials.gov Identifier: NCT02413203 |
Recruitment Status :
Completed
First Posted : April 9, 2015
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Screening |
Condition |
Healthy |
Interventions |
Drug: Celecoxib Drug: Placebo |
Enrollment | 20 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Celecoxib | Placebo |
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Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo. Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration. |
Oral administration of a single placebo pill. Placebo: Blood and urine collections before and 3 hours after placebo administration. |
Period Title: Overall Study | ||
Started | 10 | 10 |
Completed | 10 | 10 |
Not Completed | 0 | 0 |
Arm/Group Title | Celecoxib | Placebo | Total | |
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Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo. Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration. |
Oral administration of a single placebo pill. Placebo: Blood and urine collections before and 3 hours after placebo administration. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 10 | 10 | 20 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 10 participants | 10 participants | 20 participants | |
32.2 (8.6) | 30 (9) | 32.1 (8.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | 10 participants | 20 participants | |
Female |
4 40.0%
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3 30.0%
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7 35.0%
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Male |
6 60.0%
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7 70.0%
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13 65.0%
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Name/Title: | Garret A. FitzGerald |
Organization: | Univesrity of Pennsylvania |
Phone: | 215-898-1185 |
EMail: | garret@upenn.edu |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT02413203 |
Other Study ID Numbers: |
818658-Part B |
First Submitted: | March 19, 2015 |
First Posted: | April 9, 2015 |
Results First Submitted: | March 6, 2017 |
Results First Posted: | May 30, 2017 |
Last Update Posted: | May 30, 2017 |