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Biosynthesis of PGD2 in Vivo

2014-08-27 04:00:23 | BioPortfolio

Summary

We would like to see if aspirin could block niacin-induced flushing by analyzing blood and urine after taking aspirin.

Phase I: 5 days of 81 mg aspirin/placebo followed by 600 mg Niacin, 2 week washout and 5 days taking the alternate. The order in which this is given will be randomized or assigned by chance.

Phase II: One study week consisting of 5 days of taking 81 mg Aspirin, taken once daily, followed by a single dose of 600 mg Niacin on day 6.

Phase III: 5 days taking 81 mg Aspirin/placebo, 10 day washout in between.

Phase IV: Use of extended release niacin instead of instant release.

Phase V: A Celebrex study is necessary to explore the contribution of Cox-2 to niacin induced flushing.

Description

The purpose of this study is to look at the roles of various blood cells and their contributions of different prostaglandins. The intention is that by better understanding these prostaglandins and various metabolites, it will provide insights into their roles in the cardiovascular system.

Prostaglandins and metabolites are naturally occurring substances found in the blood and urine which can act as markers which can be quantified and studied as we will be doing in this study. Flushing response to niacin will also be assessed by laser doppler measuring blood flow of the facial skin.

Untransformed and transformed data will be subjected to exploratory analysis of variance appropriated for a three factor design with one two period crossover factor and two non-repeated factors. Additionally, volunteer's test(s) for paired observations will characterize the magnitude of the niacin effect on the response variables within selected time points.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Conditions

Healthy Volunteer

Intervention

5 days of placebo followed by 600mg niacin, aspirin first, 81 mg Aspirin, Niaspan, Celebrex and niacin

Location

University of Pennsylvania Hospital
Phila.
Pennsylvania
United States
19104

Status

Completed

Source

University of Pennsylvania

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:23-0400

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