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Biosynthesis of PGD2 in Vivo (Niacin)

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01275300
First received: December 16, 2010
Last updated: May 14, 2013
Last verified: March 2012
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Pilot Study to Measure Plasma and Urinary Prostaglandin D2 Metabolites Evoked by Niacin

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

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.


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.


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.
Dietary Supplement: 5 days of placebo followed by 600mg niacin
600 mg niacin
Other Name: Niaspan
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:
  • baby aspirin
  • niaspan
Placebo Comparator: low dose aspirin or placebo
5 days taking either 81 mg aspirin/placebo with at least 10 day washout in between.
Drug: 81 mg Aspirin
5 days taking 81 mg Aspirin
Other Names:
  • low dose aspirin
  • baby aspirin
Active Comparator: Single dose 2 gms Niaspan for 8 days Dietary Supplement: Niaspan
dosage
Other Name: niacin
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.
Drug: Celebrex and niacin
Data will be handled exactly like phase 1.
Other Name: niacin

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275300

Locations
United States, Pennsylvania
University of Pennsylvania Hospital
Phila., Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
American Heart Association
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01275300     History of Changes
Other Study ID Numbers: 806115 - FitzGerald, MD, American Heart Association
Study First Received: December 16, 2010
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board
United States: Office of Human Resources

Additional relevant MeSH terms:
Aspirin
Celecoxib
Niacin
Niacinamide
Nicotinic Acids
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimetabolites
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Growth Substances
Hematologic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents

ClinicalTrials.gov processed this record on November 25, 2014