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Biosynthesis of PGD2 in Vivo

NCT01275300 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-02-09

Study results available
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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

Interventions

DRUG

Aspirin

DRUG

Placebo

DRUG

Niacin

Sponsors & Collaborators

Principal Investigators

  • Wenliang Song, MD · University of Pennsylvania

  • Garret FitzGerald, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01275300 on ClinicalTrials.gov