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

Diabetes Mellitus, Type 2 Clinical Trial

— RITE  

Official title:

Reliable Inhibition of Thrombocyte Activity: Comparison of PL2200 Aspirin Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008942
• Other study ID #: PL-ASA-006
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2013
• Last updated: February 9, 2016
• Start date: January 2014
• Est. completion date: April 2014

Study information

• Verified date: February 2016
• Source: PLx Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: MidLands Independent Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• PL2200 Aspirin Capsules
325 mg aspirin; once per day for 10 days
• Enteric-coated aspirin caplets
325 mg aspirin; once per day for 10 days

Locations

Country	Name	City	State
United States	Medpace Clinical Pharmacology	Cincinnati	Ohio
United States	PRA Clinical Pharmacology Center	Lenexa	Kansas
United States	Miami Research Associates	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
PLx Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	11 days	No