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

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ClinicalTrials.gov Identifier: NCT02008942
Recruitment Status : Completed
First Posted : December 11, 2013
Results First Posted : September 4, 2015
Last Update Posted : March 10, 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: Enteric-coated aspirin caplets
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PL2200 Aspirin First, Then Enteric Coated (EC) Aspirin Enteric Coated (EC) Aspirin First, Then PL2200 Aspirin
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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

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

Period Title: First Intervention
Started 27 30
Completed 27 30
Not Completed 0 0
Period Title: Second Intervention
Started 26 30
Completed 25 30
Not Completed 1 0
Arm/Group Title All Study Participants
Hide Arm/Group Description All patients that received at least 1 dose of study drug
Overall Number of Baseline Participants 57
Hide Baseline Analysis Population Description
All patients that received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants
54.8  (10.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants
Female
36
  63.2%
Male
21
  36.8%
1.Primary Outcome
Title Time to 99% Inhibition of Serum Thromboxane
Hide Description 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.
Time Frame 11 days
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Hide Analysis Population Description
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.
Arm/Group Title PL2200 Aspirin Capsules Enteric-coated Aspirin Caplets
Hide Arm/Group Description:

PL2200 Aspirin Capsules

PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days

Enteric-coated aspirin caplets

Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days

Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: hours
26.71  (62.758) 64.57  (72.842)
Time Frame [Not Specified]
Adverse Event Reporting Description Intent-to-Treat Population: patients that received at least 1 dose of study drug.
 
Arm/Group Title PL2200 Aspirin Capsules Enteric-coated Aspirin Caplets
Hide Arm/Group Description

PL2200 Aspirin Capsules

PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days

Enteric-coated aspirin caplets

Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days

All-Cause Mortality
PL2200 Aspirin Capsules Enteric-coated Aspirin Caplets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PL2200 Aspirin Capsules Enteric-coated Aspirin Caplets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/57 (0.00%)      0/56 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
PL2200 Aspirin Capsules Enteric-coated Aspirin Caplets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/57 (3.51%)      2/56 (3.57%)    
Infections and infestations     
Upper Respiratory Infection  2/57 (3.51%)  2 2/56 (3.57%)  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
Name/Title: Ronald Zimmerman, President & CEO
Organization: PLx Pharma
Phone: 713-842-1249 ext 205
Responsible Party: PLx Pharma
ClinicalTrials.gov Identifier: NCT02008942     History of Changes
Other Study ID Numbers: PL-ASA-006
First Submitted: December 6, 2013
First Posted: December 11, 2013
Results First Submitted: June 29, 2015
Results First Posted: September 4, 2015
Last Update Posted: March 10, 2016