Trial Outcomes & Findings for Biosynthesis of PGD2 in Vivo (NCT NCT01275300)

Last Updated: 2026-02-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

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

Results posted on

2026-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	"Placebo+Niacin First, Then Aspirin+Niacin 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	Aspirin+Niacin First, Then Placebo+Niacin 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
1st Intervention (5 Days) STARTED	5	4
1st Intervention (5 Days) COMPLETED	5	4
1st Intervention (5 Days) NOT COMPLETED	0	0
Washout (14 Days) STARTED	5	4
Washout (14 Days) COMPLETED	5	4
Washout (14 Days) NOT COMPLETED	0	0
2nd Intervention(5 Days) STARTED	5	4
2nd Intervention(5 Days) COMPLETED	5	4
2nd Intervention(5 Days) NOT COMPLETED	0	0
Phase 2: Open-label 6days) STARTED	5	4
Phase 2: Open-label 6days) COMPLETED	5	4
Phase 2: Open-label 6days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Biosynthesis of PGD2 in Vivo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=9 Participants All participants had the same experience of interventions throughout the study, just in different randomized orders of receipt.
Age, Categorical <=18 years	0 Participants n=362 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=362 Participants
Age, Categorical >=65 years	0 Participants n=362 Participants
Age, Continuous	34 years STANDARD_DEVIATION 3 • n=362 Participants
Sex: Female, Male Female	4 Participants n=362 Participants
Sex: Female, Male Male	5 Participants n=362 Participants
Region of Enrollment United States	9 participants n=362 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants	Aspirin n=9 Participants
Percentage Change of Area Under Curve for the Urinary Prostaglandins Concentration Versus Time Curve (AUC) in Response to Aspirin or Placebo	95 Percentage change of area under curve Interval 93.0 to 97.0	43 Percentage change of area under curve Interval 38.0 to 48.0

Adverse Events

P1: Placebo/Aspirin Followed by Niacin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

P2: Aspirin and Niacin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Wenliang Song, MD

Upenn

Phone: 215-662-4652.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place