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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

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: PL2200 Aspirin Capsules Drug: Immediate-Release Aspirin Tablets Drug: Enteric-coated aspirin caplets Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Actively Controlled, Crossover Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Patients With Type II Diabetes
Study Start Date : January 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PL2200 Aspirin Capsules
Investigational drug arm; crossover design
Drug: PL2200 Aspirin Capsules
325 mg aspirin; once per day for 3 days
Active Comparator: Immediate-Release Aspirin Tablets
Active comparator; crossover design
Drug: Immediate-Release Aspirin Tablets
325 mg aspirin; once per day for 3 days
Active Comparator: Enteric-coated aspirin caplets
Active comparator; crossover design
Drug: Enteric-coated aspirin caplets
325 mg aspirin; once per day for 3 days



Primary Outcome Measures :
  1. Time to 99% Inhibition of Serum Thromboxane (TxB2) [ Time Frame: 4 days ]
    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.



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Ages Eligible for Study:   21 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 21-79
  • Body mass index (BMI) of 30-40 kg/m2
  • Non-insulin-dependent type-2 diabetics (as confirmed by hemoglobin A1c (HbA1c) of > 6.4% and/or fasting plasma glucose of >125 mg/dL or current anti-diabetic medication)
  • AA-induced platelet aggregation response of >60% within 3 hours prior to initial dose of study drug administration

Exclusion Criteria:

  • Contraindications to aspirin
  • Previous history of vascular disease
  • Patient requires insulin
  • Use of non-steroidal anti-inflammatory drugs, anti-secretory agents, antacids, and salicylate-containing nutritional supplements within 2 weeks of randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515657


Locations
United States, Ohio
MedPace Clinical Pharmacology
Cincinnati, Ohio, United States, 45212
Sponsors and Collaborators
PLx Pharma

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PLx Pharma
ClinicalTrials.gov Identifier: NCT01515657     History of Changes
Other Study ID Numbers: PL-ASA-004
First Posted: January 24, 2012    Key Record Dates
Results First Posted: September 4, 2015
Last Update Posted: March 14, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics