Biosynthesis of PGD2 in Vivo (Niacin)
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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 | Intervention | Phase |
|---|---|---|
| Healthy Volunteer | 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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
| Official Title: | A Pilot Study to Measure Plasma and Urinary Prostaglandin D2 Metabolites Evoked by Niacin |
- 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 ]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.
- 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) ]Area under the flushing response versus time curve (AUC) in response to niacin with or without pretreatment of aspirin will be studied.
| Enrollment: | 22 |
| Study Start Date: | July 2007 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Phase I, Period B
Period B: 5 days of placebo, followed by a single dose of 600mg niacin.
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Dietary Supplement: 5 days of placebo followed by 600mg niacin
600 mg niacin
Other Name: Niaspan
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| Placebo Comparator: sugar pill |
Dietary Supplement: aspirin first
5 days taking 81 mg Aspirin followed by a single dose of 600 mg Niacin
Other Names:
|
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Placebo Comparator: low dose aspirin or placebo
5 days taking either 81 mg aspirin/placebo with at least 10 day washout in between.
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Drug: 81 mg Aspirin
5 days taking 81 mg Aspirin
Other Names:
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| Active Comparator: Single dose 2 gms Niaspan for 8 days |
Dietary Supplement: Niaspan
dosage
Other Name: niacin
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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.
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Drug: Celebrex and niacin
Data will be handled exactly like phase 1.
Other Name: niacin
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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.
Eligibility
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275300
| United States, Pennsylvania | |
| University of Pennsylvania Hospital | |
| Phila., Pennsylvania, United States, 19104 | |
More Information
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01275300 History of Changes |
| Other Study ID Numbers: |
806115 - FitzGerald, MD American Heart Association |
| First Submitted: | December 16, 2010 |
| First Posted: | January 12, 2011 |
| Last Update Posted: | October 12, 2017 |
| Last Verified: | March 2012 |
Additional relevant MeSH terms:
|
Aspirin Celecoxib Niacin Niacinamide Nicotinic Acids Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents |
Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Hypolipidemic Agents Antimetabolites Lipid Regulating Agents Vasodilator Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Cyclooxygenase 2 Inhibitors |