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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-04-30

Brief Summary

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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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PL2200 Aspirin Capsules

Group Type EXPERIMENTAL

PL2200 Aspirin Capsules

Intervention Type DRUG

325 mg aspirin; once per day for 10 days

Enteric-coated aspirin caplets

Group Type ACTIVE_COMPARATOR

Enteric-coated aspirin caplets

Intervention Type DRUG

325 mg aspirin; once per day for 10 days

Interventions

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PL2200 Aspirin Capsules

325 mg aspirin; once per day for 10 days

Intervention Type DRUG

Enteric-coated aspirin caplets

325 mg aspirin; once per day for 10 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No