Biosynthesis of PGD2 in Vivo

NCT01275300 | Completed Results DMC

• 1 other identifier: 806115 - FitzGerald, MD
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator would like to see if aspirin could block niacin-induced flushing by analyzing blood and urine after taking aspirin. Phase I: Subjects were assigned to either placebo or aspirin groups. They were given 5 days of 81 mg aspirin or placebo. On day 5, they were given a single dose of niacin (600 mg) administered 30 minutes after the last dose of aspirin or placebo. The same subjects came back for cross-over study and were assigned to a different group. There was a 2-week washout period between each treatment. Urine was collected sequentially for analysis Phase II: The same study subjects come back for an open label one week study. They were given 5 days of taking 81 mg Aspirin, taken once daily, followed by a single dose of 600 mg Niacin on day 6. Urine was collected sequentially for analysis

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Percentage Change of Area Under Curve for the Urinary Prostaglandins Concentration Versus Time Curve (AUC) in Response to Aspirin or Placebo

  Percentage change of area under the urinary prostaglandins concentration versus time curve (AUC) in response to niacin with or without pretreatment of aspirin was studied. This outcome measures whether aspirin instead of placebo will impact the subjects' response to niacin. The area was normalized by percentile.

  -2-0, 0-2, 2-4, 4-6, 6-12 and 12-24 hours pre or post niacin

Study Arms (3)

Placebo phase I

PLACEBO COMPARATOR

Subjects were given 5 days of placebo. On day 5, they were given a single dose of niacin (600 mg) administered 30 minutes after the last dose of placebo. Urine was collected sequentially for analysis. The same subjects came back for cross-over study and were assigned to Aspirin group. There was a 2-week washout period between each treatment.

Drug: Placebo; Drug: Niacin

Aspirin phase I

ACTIVE COMPARATOR

Subjects were given 5 days of 81 mg aspirin. On day 5, they were given a single dose of niacin (600 mg) administered 30 minutes after the last dose of aspirin or placebo. Urine was collected sequentially for analysis.

Drug: Aspirin; Drug: Niacin

Aspirin phase II

ACTIVE COMPARATOR

In phase II study, subjects were given 5 days of 81 mg aspirin. On day 6, they were given a single dose of niacin (600 mg) administered 24 hours after the last dose of aspirin. Urine was collected sequentially for analysis

Drug: Aspirin; Drug: Niacin

Interventions

Aspirin DRUG

Also known as: Aspirin 81 mg

Aspirin phase I; Aspirin phase II

Placebo DRUG

Placebo phase I

Niacin DRUG

Also known as: Niacin 600 mg

Aspirin phase I; Aspirin phase II; Placebo phase I

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Song WL, Stubbe J, Ricciotti E, Alamuddin N, Ibrahim S, Crichton I, Prempeh M, Lawson JA, Wilensky RL, Rasmussen LM, Pure E, FitzGerald GA. Niacin and biosynthesis of PGD(2)by platelet COX-1 in mice and humans. J Clin Invest. 2012 Apr;122(4):1459-68. doi: 10.1172/JCI59262. Epub 2012 Mar 12.

  PMID: 22406532 RESULT

Related Links

• Niacin and biosynthesis of PGD2 by platelet COX-1 in mice and humans

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Aspirin; Niacin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Wenliang Song, MD
• Organization: Upenn

wenliangsong@gmail.com

215-662-4652.

Study Officials

• Wenliang Song, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Garret FitzGerald, MD

  University of Pennsylvania

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: January 12, 2011
• Study Start: July 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 9, 2026
• Results First Posted: July 9, 2020

Record last verified: 2026-01

Locations

US (1)