N/A
N=9
Biosynthesis of PGD2 in Vivo
Hyperlipidemia
Bottom Line
View on ClinicalTrials.gov: NCT01275300 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Percentage Change of Area Under Curve for the Urinary Prostaglandins Concentration Versus Time Curve (AUC) in Response to Aspirin or Placebo — 95; 43 Percentage change of area under curve
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aspirin (Drug); Placebo (Drug); Niacin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change of Area Under Curve for the Urinary Prostaglandins Concentration Versus Time Curve (AUC) in Response to Aspirin or Placebo |
95; 43 | — |
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
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.
Data sourced from ClinicalTrials.gov (NCT01275300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.