Trial Outcomes & Findings for Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients (NCT NCT02008942)

Results Overview

Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

57 participants

Primary outcome timeframe

11 days

Results posted on

2016-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	PL2200 Aspirin First, Then Enteric Coated (EC) Aspirin First Intervention Period: PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days (after 2-week washout period) Second Intervention Period: EC aspirin: 325 mg aspirin; once per day for 10 days	Enteric Coated (EC) Aspirin First, Then PL2200 Aspirin First Intervention Period: EC aspirin: 325 mg aspirin; once per day for 10 days (after 2-week washout period) Second Intervention Period: PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days
First Intervention STARTED	27	30
First Intervention COMPLETED	27	30
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	26	30
Second Intervention COMPLETED	25	30
Second Intervention NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=57 Participants All patients that received at least 1 dose of study drug
Age, Continuous	54.8 years STANDARD_DEVIATION 10.06 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 11 days

Population: Pharmacodynamic (PD) Evaluable Population - patients in the intent-to-treat population who received a full treatment regimen for each of 2 study drugs, had all scheduled PD blood draws, and had no other major protocol violations.

Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.

Outcome measures

Outcome measures
Measure	PL2200 Aspirin Capsules n=55 Participants PL2200 Aspirin Capsules PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days	Enteric-coated Aspirin Caplets n=55 Participants Enteric-coated aspirin caplets Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days
Time to 99% Inhibition of Serum Thromboxane	26.71 hours Standard Deviation 62.758	64.57 hours Standard Deviation 72.842

Adverse Events

PL2200 Aspirin Capsules

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Enteric-coated Aspirin Caplets

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PL2200 Aspirin Capsules n=57 participants at risk PL2200 Aspirin Capsules PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days	Enteric-coated Aspirin Caplets n=56 participants at risk Enteric-coated aspirin caplets Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days
Infections and infestations Upper Respiratory Infection	3.5% 2/57 • Number of events 2 Intent-to-Treat Population: patients that received at least 1 dose of study drug.	3.6% 2/56 • Number of events 2 Intent-to-Treat Population: patients that received at least 1 dose of study drug.

Additional Information

Ronald Zimmerman, President & CEO

PLx Pharma

Phone: 713-842-1249

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Standard confidentiality agreement
Publication restrictions are in place

Restriction type: OTHER