A Pilot Study to Measure Plasma and Urinary Prostaglandin D2 Metabolites Evoked by Niacin
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| City: |
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Phila. |
| State: |
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Pennsylvania |
| Zip Code: |
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19104 |
| Conditions: |
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Healthy Volunteer |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT01275300 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Phila., Pennsylvania 19104
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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