Biosynthesis of PGD2 in Vivo | RxWiki

Biosynthesis of PGD2 in Vivo

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Healthy Volunteer
Intervention	Dietary Supplement: 5 days of placebo followed by 600mg niacin Dietary Supplement: aspirin first Drug: 81 mg Aspirin Dietary Supplement: Niaspan Drug: Celebrex and niacin
Phase	Phase 4
Sponsor	University of Pennsylvania
Responsible Party	University of Pennsylvania
ClinicalTrials.gov Identifier	NCT01275300
First Received	December 16, 2010
Last Updated	May 14, 2013
Last verified	March 2012

Tracking Information[ + expand ][ + ]

First Received Date	December 16, 2010
Last Updated Date	May 14, 2013
Start Date	July 2007
Estimated Primary Completion Date	January 2012
Current Primary Outcome Measures	Area under the urinary prostaglandins concentration versus time curve (AUC) in response to niacin and aspirin [Time Frame: -2-0, 0-2, 2-4, 4-6, 6-12 and 12-24 hours pre or post niacin] [Designated as safety issue: No]Area under the urinary prostaglandins concentration versus time curve (AUC) in response to niacin with or without pretreatment of aspirin will be studied. Area under the urinary prostaglandins concentration versus time curve (AUC) in response to aspirin will also be studied.
Current Secondary Outcome Measures	Area under the flushing response versus time curve (AUC) in response to niacin [Time Frame: 5 mins before niacin to 6 hours after niacin administertion (continuously)] [Designated as safety issue: No]Area under the flushing response versus time curve (AUC) in response to niacin with or without pretreatment of aspirin will be studied.

Descriptive Information[ + expand ][ + ]

Brief Title	Biosynthesis of PGD2 in Vivo
Official Title	A Pilot Study to Measure Plasma and Urinary Prostaglandin D2 Metabolites Evoked by Niacin
Brief 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.
Detailed 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 Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Condition	Healthy Volunteer
Intervention	Dietary Supplement: 5 days of placebo followed by 600mg niacin 600 mg niacin Other Names: NiaspanDietary Supplement: aspirin first 5 days taking 81 mg Aspirin followed by a single dose of 600 mg Niacin Other Names: baby aspirin niaspan Drug: 81 mg Aspirin 5 days taking 81 mg Aspirin Other Names: low dose aspirin baby aspirin Dietary Supplement: Niaspan dosage Other Names: niacinDrug: Celebrex and niacin Data will be handled exactly like phase 1. Other Names: niacin
Study Arm (s)	Placebo Comparator: Phase I, Period B Period B: 5 days of placebo, followed by a single dose of 600mg niacin. Placebo Comparator: sugar pill Placebo Comparator: low dose aspirin or placebo 5 days taking either 81 mg aspirin/placebo with at least 10 day washout in between. Active Comparator: Single dose 2 gms Niaspan for 8 days Placebo Comparator: Celebrex / Placebo Celebrex 200 mg/Placebo taken for 5 days, two times daily, followed by single dose of 600 mg niacin on day five. At least 10 days in between each dosing period.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	22
Estimated Completion Date	January 2012
Estimated Primary Completion Date	January 2012
Eligibility Criteria	Inclusion Criteria: age between 18-70 - subject must be in good health as based on medical history - All subjects must be non-smoking, non-pregnant volunteers - Female subjects of child bearing potential must be using a medically acceptable method of contraception throughout the entire study period. All female subjects must consent to a urine pregnancy test at screening and just prior to the start of each treatment period of the study, which must be negative at all time points. Exclusion Criteria: - subjects with any medical condition that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject. - subjects who have received an experimental drug within 30 days prior to the study. - subjects who have taken medications at least 10 days prior to the study. Birth Control pills are acceptable and shall not be excluded. - Subjects who have taken aspirin or aspirin containing products for at least 10 days prior to the study. - Subjects who have taken acetaminophen, NSAIDS, COX-2 inhibitors (OTC or prescription) for at least 10 days prior to the study. - Subjects who are currently consuming any type of tobacco product(s). - Subjects who consume high doses of antioxidant vitamins daily (vitamin C > 1000mg, Vitamin E > 400 IU, Beta Carotene > 1000IU, Vitamin A > 5000IU, Selenium > 200mcg, Folic Acid > 1mg) for the 2 weeks prior to the start of the study and throughout the study. - Subjects who consume alcohol, caffeine or high fat food 24 hours prior to study.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01275300
Other Study ID Numbers	806115 - FitzGerald, MD
Has Data Monitoring Committee	Yes
Information Provided By	University of Pennsylvania
Study Sponsor	University of Pennsylvania
Collaborators	American Heart Association
Investigators	Not Provided
Verification Date	March 2012

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