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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PLx Pharma
ClinicalTrials.gov Identifier:
NCT01515657
First received: January 13, 2012
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

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 elderly patients with diabetes.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, 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

Resource links provided by NLM:

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

Further study details as provided by PLx Pharma:

Primary Outcome Measures:
  • Pharmacodynamic bioequivalence [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Serial measures of aspirin anti-platelet activity will be collected over 4 days, and compared between groups, to allow a determination of pharmcodynamic (anti-platelet) bioequivalance between study drugs.


Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
    Assessment and comparison of the incidence of adverse events between treatment groups; changes in clinical laboratory parameters from baseline and between treatment groups; and changes in vital signs from baseline and between treatment groups.

  • Pharmacokinetic bioequivalance [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Serial measures of aspirin plasma levels will be collected over 4 days, and compared between groups, to allow a determination of pharmcokinetic bioequivalance between study drugs.


Estimated Enrollment: 40
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 50-79
  • Non-insulin-dependent type-2 diabetics

Exclusion Criteria:

  • Contraindications to aspirin
  • Significant disease history or active disease other than type-2 diabetes
  • Patient requires insulin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515657

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

No publications provided

Responsible Party: PLx Pharma
ClinicalTrials.gov Identifier: NCT01515657     History of Changes
Other Study ID Numbers: PL-ASA-004
Study First Received: January 13, 2012
Last Updated: June 29, 2012
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013