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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PL2200 Aspirin Capsules | Experimental | Investigational drug arm; crossover design |
|
| Immediate-Release Aspirin Tablets | Active Comparator | Active comparator; crossover design |
|
| Enteric-coated aspirin caplets | Active Comparator | Active comparator; crossover design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PL2200 Aspirin Capsules | Drug | 325 mg aspirin; once per day for 3 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to 99% Inhibition of Serum Thromboxane (TxB2) | 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. | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedPace Clinical Pharmacology | Cincinnati | Ohio | 45212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28089180 | Derived | Bhatt DL, Grosser T, Dong JF, Logan D, Jeske W, Angiolillo DJ, Frelinger AL 3rd, Lei L, Liang J, Moore JE, Cryer B, Marathi U. Enteric Coating and Aspirin Nonresponsiveness in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol. 2017 Feb 14;69(6):603-612. doi: 10.1016/j.jacc.2016.11.050. Epub 2017 Jan 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PL2200 Aspirin First, Then IR Aspirin Tablets, Then EC Aspirin | First Intervention Period: PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period) Second Intervention Period: IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period) Third Intervention Period: EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
|
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| Immediate-Release Aspirin Tablets |
| Drug |
325 mg aspirin; once per day for 3 days |
|
| Enteric-coated aspirin caplets | Drug | 325 mg aspirin; once per day for 3 days |
|
| FG001 | IR Aspirin Tablets First, Then EC Aspirin, Then PL2200 Aspirin | First Intervention Period: IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period) Second Intervention Period: EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period) Third Intervention Period: PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days |
| FG002 | EC Aspirin First, Then PL2200 Aspirin, Then IR Aspirin Tablets | First Intervention Period: EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period) Second Intervention Period: PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period) Third Intervention Period: IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days |
| COMPLETED |
|
| NOT COMPLETED |
|
| Second Intervention |
|
| Third Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All patients that received at least 1 dose of study drug under the study protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to 99% Inhibition of Serum Thromboxane (TxB2) | 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. | Pharmacodynamic (PD) Evaluable Population for Time to 99% Inhibition | Posted | Mean | Standard Deviation | Hours | 4 days |
|
|
|
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modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PL2200 Aspirin Capsules | Investigational drug arm; crossover design PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days | 0 | 38 | 2 | 38 | ||
| EG001 | Immediate-Release Aspirin Tablets | Active comparator; crossover design Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days | 0 | 40 | 4 | 40 | ||
| EG002 | Enteric-coated Aspirin Caplets | Active comparator; crossover design Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days | 0 | 38 | 7 | 38 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
| |||
| Viral Infection | Infections and infestations |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
|
Standard confidentiality agreement
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Zimmerman | PLx Pharma | 1-713-842-1249 | 205 | ron.zimmerman@plxpharma.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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