Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2026-04-14 @ 8:01 PM
Study NCT ID:
NCT01515657
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
2012-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ron.zimmerman@plxpharma.com', 'phone': '1-713-842-1249', 'title': 'Ronald Zimmerman', 'phoneExt': '205', 'organization': 'PLx Pharma'}, 'certainAgreement': {'otherDetails': 'Standard confidentiality agreement', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'modified Intent-to-Treat population: all patients that received at least 1 dose of study drug under the study protocol', 'eventGroups': [{'id': 'EG000', 'title': 'PL2200 Aspirin Capsules', 'description': 'Investigational drug arm; crossover design\n\nPL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days', 'otherNumAtRisk': 38, 'otherNumAffected': 2, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Immediate-Release Aspirin Tablets', 'description': 'Active comparator; crossover design\n\nImmediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days', 'otherNumAtRisk': 40, 'otherNumAffected': 4, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Enteric-coated Aspirin Caplets', 'description': 'Active comparator; crossover design\n\nEnteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days', 'otherNumAtRisk': 38, 'otherNumAffected': 7, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to 99% Inhibition of Serum Thromboxane (TxB2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PL2200 Aspirin Capsules', 'description': 'Investigational drug arm; crossover design\n\nPL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days'}, {'id': 'OG001', 'title': 'Immediate-Release Aspirin Tablets', 'description': 'Active comparator; crossover design\n\nImmediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days'}, {'id': 'OG002', 'title': 'Enteric-coated Aspirin Caplets', 'description': 'Active comparator; crossover design\n\nEnteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '12.36', 'spread': '23.42', 'groupId': 'OG000'}, {'value': '16.65', 'spread': '27.21', 'groupId': 'OG001'}, {'value': '48.64', 'spread': '31.20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': "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.", 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) Evaluable Population for Time to 99% Inhibition'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PL2200 Aspirin First, Then IR Aspirin Tablets, Then EC Aspirin', 'description': 'First Intervention Period:\n\nPL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period)\n\nSecond Intervention Period:\n\nIR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period)\n\nThird Intervention Period:\n\nEC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days'}, {'id': 'FG001', 'title': 'IR Aspirin Tablets First, Then EC Aspirin, Then PL2200 Aspirin', 'description': 'First Intervention Period:\n\nIR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period)\n\nSecond Intervention Period:\n\nEC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period)\n\nThird Intervention Period:\n\nPL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days'}, {'id': 'FG002', 'title': 'EC Aspirin First, Then PL2200 Aspirin, Then IR Aspirin Tablets', 'description': 'First Intervention Period:\n\nEC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period)\n\nSecond Intervention Period:\n\nPL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period)\n\nThird Intervention Period:\n\nIR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All patients that received at least 1 dose of study drug under the study protocol.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'spread': '10.12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-11', 'studyFirstSubmitDate': '2012-01-13', 'resultsFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2012-01-18', 'lastUpdatePostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-05', 'studyFirstPostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to 99% Inhibition of Serum Thromboxane (TxB2)', 'timeFrame': '4 days', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '28089180', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 21-79\n* Body mass index (BMI) of 30-40 kg/m2\n* 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)\n* AA-induced platelet aggregation response of \\>60% within 3 hours prior to initial dose of study drug administration\n\nExclusion Criteria:\n\n* Contraindications to aspirin\n* Previous history of vascular disease\n* Patient requires insulin\n* Use of non-steroidal anti-inflammatory drugs, anti-secretory agents, antacids, and salicylate-containing nutritional supplements within 2 weeks of randomization'}, 'identificationModule': {'nctId': 'NCT01515657', 'briefTitle': 'Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'PLx Pharma'}, 'officialTitle': 'A Randomized, Actively Controlled, Crossover Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Patients With Type II Diabetes', 'orgStudyIdInfo': {'id': 'PL-ASA-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PL2200 Aspirin Capsules', 'description': 'Investigational drug arm; crossover design', 'interventionNames': ['Drug: PL2200 Aspirin Capsules']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate-Release Aspirin Tablets', 'description': 'Active comparator; crossover design', 'interventionNames': ['Drug: Immediate-Release Aspirin Tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enteric-coated aspirin caplets', 'description': 'Active comparator; crossover design', 'interventionNames': ['Drug: Enteric-coated aspirin caplets']}], 'interventions': [{'name': 'PL2200 Aspirin Capsules', 'type': 'DRUG', 'description': '325 mg aspirin; once per day for 3 days', 'armGroupLabels': ['PL2200 Aspirin Capsules']}, {'name': 'Immediate-Release Aspirin Tablets', 'type': 'DRUG', 'description': '325 mg aspirin; once per day for 3 days', 'armGroupLabels': ['Immediate-Release Aspirin Tablets']}, {'name': 'Enteric-coated aspirin caplets', 'type': 'DRUG', 'description': '325 mg aspirin; once per day for 3 days', 'armGroupLabels': ['Enteric-coated aspirin caplets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'MedPace Clinical Pharmacology', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PLx Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}