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Trial record 11 of 87 for:    ASPIRIN AND thromboxane

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

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ClinicalTrials.gov Identifier: NCT01515657
Recruitment Status : Completed
First Posted : January 24, 2012
Results First Posted : September 4, 2015
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
PLx Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Diabetes Mellitus, Type 2
Interventions Drug: PL2200 Aspirin Capsules
Drug: Immediate-Release Aspirin Tablets
Drug: Enteric-coated aspirin caplets
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PL2200 Aspirin First, Then IR Aspirin Tablets, Then EC Aspirin IR Aspirin Tablets First, Then EC Aspirin, Then PL2200 Aspirin EC Aspirin First, Then PL2200 Aspirin, Then IR Aspirin Tablets
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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

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

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

Period Title: First Intervention
Started 14 13 13
Completed 14 12 13
Not Completed 0 1 0
Period Title: Second Intervention
Started 14 12 13
Completed 14 11 13
Not Completed 0 1 0
Period Title: Third Intervention
Started 14 11 13
Completed 13 11 13
Not Completed 1 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description All patients that received at least 1 dose of study drug under the study protocol.
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
52.9  (10.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
14
  35.0%
Male
26
  65.0%
1.Primary Outcome
Title Time to 99% Inhibition of Serum Thromboxane (TxB2)
Hide Description 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.
Time Frame 4 days
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Hide Analysis Population Description
Pharmacodynamic (PD) Evaluable Population for Time to 99% Inhibition
Arm/Group Title PL2200 Aspirin Capsules Immediate-Release Aspirin Tablets Enteric-coated Aspirin Caplets
Hide Arm/Group Description:

Investigational drug arm; crossover design

PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days

Active comparator; crossover design

Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days

Active comparator; crossover design

Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days

Overall Number of Participants Analyzed 35 35 35
Mean (Standard Deviation)
Unit of Measure: Hours
12.36  (23.42) 16.65  (27.21) 48.64  (31.20)
Time Frame [Not Specified]
Adverse Event Reporting Description modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol
 
Arm/Group Title PL2200 Aspirin Capsules Immediate-Release Aspirin Tablets Enteric-coated Aspirin Caplets
Hide Arm/Group Description

Investigational drug arm; crossover design

PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days

Active comparator; crossover design

Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days

Active comparator; crossover design

Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days

All-Cause Mortality
PL2200 Aspirin Capsules Immediate-Release Aspirin Tablets Enteric-coated Aspirin Caplets
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PL2200 Aspirin Capsules Immediate-Release Aspirin Tablets Enteric-coated Aspirin Caplets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/40 (0.00%)      0/38 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PL2200 Aspirin Capsules Immediate-Release Aspirin Tablets Enteric-coated Aspirin Caplets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/38 (5.26%)      4/40 (10.00%)      7/38 (18.42%)    
Gastrointestinal disorders       
Nausea  2/38 (5.26%)  2 1/40 (2.50%)  1 1/38 (2.63%)  1
Infections and infestations       
Viral Infection  0/38 (0.00%)  0 1/40 (2.50%)  1 2/38 (5.26%)  2
Nervous system disorders       
Dizziness  0/38 (0.00%)  0 0/40 (0.00%)  0 2/38 (5.26%)  2
Headache  0/38 (0.00%)  0 2/40 (5.00%)  2 2/38 (5.26%)  2
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Standard confidentiality agreement
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ronald Zimmerman
Organization: PLx Pharma
Phone: 1-713-842-1249 ext 205
EMail: ron.zimmerman@plxpharma.com
Layout table for additonal information
Responsible Party: PLx Pharma
ClinicalTrials.gov Identifier: NCT01515657     History of Changes
Other Study ID Numbers: PL-ASA-004
First Submitted: January 13, 2012
First Posted: January 24, 2012
Results First Submitted: June 22, 2015
Results First Posted: September 4, 2015
Last Update Posted: March 14, 2016