drugset / Trial / NCT01275300

Biosynthesis of PGD2 in Vivo

NCT01275300

Completed 9 enrolled University of Pennsylvania
RandomizedCrossoverDouble-blindBasic science

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

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 81 mg
Comparator Niacin Small molecule 600 mg

Indications