Trial Outcomes & Findings for Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients (NCT NCT01515657)
NCT ID: NCT01515657
Last Updated: 2016-03-14
Results Overview
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
40 participants
Primary outcome timeframe
4 days
Results posted on
2016-03-14
Participant Flow
Participant milestones
| Measure |
PL2200 Aspirin First, Then IR Aspirin Tablets, Then EC Aspirin
First Intervention Period:
PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period)
Second Intervention Period:
IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period)
Third Intervention Period:
EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days
|
IR Aspirin Tablets First, Then EC Aspirin, Then PL2200 Aspirin
First Intervention Period:
IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period)
Second Intervention Period:
EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period)
Third Intervention Period:
PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days
|
EC Aspirin First, Then PL2200 Aspirin, Then IR Aspirin Tablets
First Intervention Period:
EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period)
Second Intervention Period:
PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period)
Third Intervention Period:
IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days
|
|---|---|---|---|
|
First Intervention
STARTED
|
14
|
13
|
13
|
|
First Intervention
COMPLETED
|
14
|
12
|
13
|
|
First Intervention
NOT COMPLETED
|
0
|
1
|
0
|
|
Second Intervention
STARTED
|
14
|
12
|
13
|
|
Second Intervention
COMPLETED
|
14
|
11
|
13
|
|
Second Intervention
NOT COMPLETED
|
0
|
1
|
0
|
|
Third Intervention
STARTED
|
14
|
11
|
13
|
|
Third Intervention
COMPLETED
|
13
|
11
|
13
|
|
Third Intervention
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients
Baseline characteristics by cohort
| Measure |
All Study Participants
n=40 Participants
All patients that received at least 1 dose of study drug under the study protocol.
|
|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 10.12 • n=93 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 4 daysPopulation: Pharmacodynamic (PD) Evaluable Population for Time to 99% Inhibition
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
| Measure |
PL2200 Aspirin Capsules
n=35 Participants
Investigational drug arm; crossover design
PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days
|
Immediate-Release Aspirin Tablets
n=35 Participants
Active comparator; crossover design
Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days
|
Enteric-coated Aspirin Caplets
n=35 Participants
Active comparator; crossover design
Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days
|
|---|---|---|---|
|
Time to 99% Inhibition of Serum Thromboxane (TxB2)
|
12.36 Hours
Standard Deviation 23.42
|
16.65 Hours
Standard Deviation 27.21
|
48.64 Hours
Standard Deviation 31.20
|
Adverse Events
PL2200 Aspirin Capsules
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Immediate-Release Aspirin Tablets
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Enteric-coated Aspirin Caplets
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PL2200 Aspirin Capsules
n=38 participants at risk
Investigational drug arm; crossover design
PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days
|
Immediate-Release Aspirin Tablets
n=40 participants at risk
Active comparator; crossover design
Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days
|
Enteric-coated Aspirin Caplets
n=38 participants at risk
Active comparator; crossover design
Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.3%
2/38 • Number of events 2
modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol
|
2.5%
1/40 • Number of events 1
modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol
|
2.6%
1/38 • Number of events 1
modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol
|
|
Infections and infestations
Viral Infection
|
0.00%
0/38
modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol
|
2.5%
1/40 • Number of events 1
modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol
|
5.3%
2/38 • Number of events 2
modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol
|
|
Nervous system disorders
Dizziness
|
0.00%
0/38
modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol
|
0.00%
0/40
modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol
|
5.3%
2/38 • Number of events 2
modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol
|
|
Nervous system disorders
Headache
|
0.00%
0/38
modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol
|
5.0%
2/40 • Number of events 2
modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol
|
5.3%
2/38 • Number of events 2
modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Standard confidentiality agreement
- Publication restrictions are in place
Restriction type: OTHER