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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PL2200 Aspirin Capsules
Enteric-coated aspirin caplets
Sponsored by
PLx Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Non-Insulin-Dependent Diabetes Mellitus
  • Adults 21 to 79 years, inclusive
  • Body mass index between 30 and 40 kg/m2, inclusive

Exclusion Criteria:

  • Currently prescribed aspirin or anti-coagulants
  • Contraindications to aspirin
  • Significant disease history or active disease other than Non-Insulin-Dependent Diabetes Mellitus
  • Patient requires insulin

Sites / Locations

  • Miami Research Associates
  • PRA Clinical Pharmacology Center
  • Medpace Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PL2200 Aspirin Capsules

Enteric-coated aspirin caplets

Arm Description

PL2200 Aspirin Capsules

Enteric-coated aspirin caplets

Outcomes

Primary Outcome Measures

Time to 99% Inhibition of Serum Thromboxane
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.

Secondary Outcome Measures

Full Information

First Posted
December 6, 2013
Last Updated
February 9, 2016
Sponsor
PLx Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02008942
Brief Title
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients
Acronym
RITE
Official Title
Reliable Inhibition of Thrombocyte Activity: Comparison of PL2200 Aspirin Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PLx Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as enteric coated aspirin, when administered to patients with diabetes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PL2200 Aspirin Capsules
Arm Type
Experimental
Arm Description
PL2200 Aspirin Capsules
Arm Title
Enteric-coated aspirin caplets
Arm Type
Active Comparator
Arm Description
Enteric-coated aspirin caplets
Intervention Type
Drug
Intervention Name(s)
PL2200 Aspirin Capsules
Intervention Description
325 mg aspirin; once per day for 10 days
Intervention Type
Drug
Intervention Name(s)
Enteric-coated aspirin caplets
Intervention Description
325 mg aspirin; once per day for 10 days
Primary Outcome Measure Information:
Title
Time to 99% Inhibition of Serum Thromboxane
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-Insulin-Dependent Diabetes Mellitus Adults 21 to 79 years, inclusive Body mass index between 30 and 40 kg/m2, inclusive Exclusion Criteria: Currently prescribed aspirin or anti-coagulants Contraindications to aspirin Significant disease history or active disease other than Non-Insulin-Dependent Diabetes Mellitus Patient requires insulin
Facility Information:
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
PRA Clinical Pharmacology Center
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Medpace Clinical Pharmacology
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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