Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-27 @ 11:06 PM
Study NCT ID:
NCT00872534
Status:
COMPLETED
Last Update Posted:
2015-08-11
First Post:
2009-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ron.zimmerman@plxpharma.com', 'phone': '1-713-842-1249', 'title': 'Ronald Zimmerman, CEO & President', 'phoneExt': '205', 'organization': 'PLx Pharma'}, 'certainAgreement': {'otherDetails': 'Standard Confidentiality Agreement', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PL-2200', 'description': 'PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.\n\nacetylsalicylic acid: 325mg once a day for 7 days', 'otherNumAtRisk': 100, 'otherNumAffected': 8, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aspirin', 'description': 'Immediate release 325mg aspirin\n\nacetylsalicylic acid: 325mg once a day for 7 days', 'otherNumAtRisk': 104, 'otherNumAffected': 14, 'seriousNumAtRisk': 104, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Stomach Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Subjects With Gastroduodenal Erosions and Ulcers.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PL-2200', 'description': 'PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.\n\nacetylsalicylic acid: 325mg once a day for 7 days'}, {'id': 'OG001', 'title': 'Aspirin', 'description': 'Immediate release 325mg aspirin\n\nacetylsalicylic acid: 325mg once a day for 7 days'}], 'classes': [{'title': 'Gastroduodenal Composite Score of 3 or 4 (NO)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Gastroduodenal Composite Score of 3 or 4 (YES)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 7 days of study medication', 'description': 'Incidence of subjects with gastroduodenal composite scores of 3 or 4 (\\> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PL-2200', 'description': 'PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.\n\nacetylsalicylic acid: 325mg once a day for 7 days'}, {'id': 'FG001', 'title': 'Aspirin', 'description': 'Immediate release 325mg aspirin\n\nacetylsalicylic acid: 325mg once a day for 7 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PL-2200', 'description': 'PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.\n\nacetylsalicylic acid: 325mg once a day for 7 days'}, {'id': 'BG001', 'title': 'Aspirin', 'description': 'Immediate release 325mg aspirin\n\nacetylsalicylic acid: 325mg once a day for 7 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '6.35', 'groupId': 'BG000'}, {'value': '56.6', 'spread': '6.00', 'groupId': 'BG001'}, {'value': '57.3', 'spread': '6.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-05', 'studyFirstSubmitDate': '2009-03-10', 'resultsFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2009-03-30', 'lastUpdatePostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-05', 'studyFirstPostDateStruct': {'date': '2009-03-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Subjects With Gastroduodenal Erosions and Ulcers.', 'timeFrame': 'After 7 days of study medication', 'description': 'Incidence of subjects with gastroduodenal composite scores of 3 or 4 (\\> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['To evaluate the acute gastrointestinal safety of PL-2100.'], 'conditions': ['Upper Gastrointestinal Mucosal Damage']}, 'descriptionModule': {'briefSummary': 'To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses of aspirin (325 mg) in normal healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is ≥50 to ≤75 years of age.\n* Subject is healthy.\n* Subject has a BMI between 20 and 32\n* If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.\n\nExclusion Criteria:\n\n* Subject has abnormal screening/baseline laboratory parameters or endoscopic observations deemed clinically significant by the Investigator.\n* Subject has an active Helicobacter pylori infection.\n* Subject has a prior GI ulcer, bleeding, obstruction or perforation.\n* Subject has taken aspirin or any aspirin containing product within the last 4 weeks, or a non-aspirin NSAID product within 2 weeks.\n* Subject has taken any of the following medications within 2 weeks prior to enrollment: Any anti-platelet agents, anti-coagulants or selective serotonin reuptake inhibitors.\n* Subject has used an investigational agent within the past 30 days.\n* Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.'}, 'identificationModule': {'nctId': 'NCT00872534', 'briefTitle': 'Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'PLx Pharma'}, 'officialTitle': 'A Randomized, Single-Blind, Endoscopic Evaluation Of Upper GI Mucosal Damage Induced By PL-2200 Versus Aspirin In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'PL-ASA-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PL-2200', 'description': 'PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.', 'interventionNames': ['Drug: acetylsalicylic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aspirin', 'description': 'Immediate release 325mg aspirin', 'interventionNames': ['Drug: acetylsalicylic acid']}], 'interventions': [{'name': 'acetylsalicylic acid', 'type': 'DRUG', 'description': '325mg once a day for 7 days', 'armGroupLabels': ['Aspirin', 'PL-2200']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Jupiter Research', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Research Associates', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Foundation for Digestive Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Arthritis and Osteoporosis Center', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Center For Clinical Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Byron L Cryer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dallas VA'}, {'name': 'Frank L Lanza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Houston Institute for Clinical Research'}, {'name': 'Michael E Schwartz, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jupiter Research'}, {'name': 'Alan J Kivitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Altoona Arthritis and Osteoporosis Center'}, {'name': 'Phillip B Miner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oklahoma Foundation for Digestive Research'}, {'name': 'Howard Schwartz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Miami Research Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PLx Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}