Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-03-09 @ 2:36 AM
Study NCT ID:
NCT00616018
Status:
COMPLETED
Last Update Posted:
2012-07-12
First Post:
2008-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056486', 'term': 'Chemical and Drug Induced Liver Injury'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011041', 'term': 'Poisoning'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jody.green@rmpdc.org', 'phone': '303-389-1246', 'title': 'Jody Green', 'organization': 'Denver Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'One limitation is that this study did not include a placebo group. The study was limited to healthy volunteers. The ingestion of each dose and use of other medications was self-reported.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from time of first dose of study medication through followup visits.', 'eventGroups': [{'id': 'EG000', 'title': 'Acetaminophen', 'description': 'all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study', 'otherNumAtRisk': 27, 'otherNumAffected': 12, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetaminophen', 'description': 'all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0, 4, 7, 9, 11, and 14.', 'description': 'Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum.', 'unitOfMeasure': 'nmol/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based upon the 24 subjects who completed all study visits.'}, {'type': 'SECONDARY', 'title': 'Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetaminophen', 'description': 'acetaminophen treatment group'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '24.0', 'spread': '8.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '25.9', 'spread': '10.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '41.3', 'spread': '27.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '41.3', 'spread': '27.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '41.8', 'spread': '24.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '36.1', 'spread': '18.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0, 4, 7, 9, 11, and 14.', 'description': 'ALT was measured at Day 0, 4, 7, 9, 11, and 14.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based upon the 24 subjects who completed all study visits.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acetaminophen', 'description': 'all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Study was conducted from August 2007 through January 2008. Healthy volunteers were recruited through flyers posted in community settings.', 'preAssignmentDetails': 'Thirty-five subjects were consented for the study. Of these, eight were excluded (six did not meet inclusion criteria and two refused to participate). The 27 eligible subjects were assigned to the treatment arm to receive 4 grams of acetaminophen per day, for 10 consecutive days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Acetaminophen', 'description': 'all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '12.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-10', 'studyFirstSubmitDate': '2008-02-04', 'resultsFirstSubmitDate': '2011-03-03', 'studyFirstSubmitQcDate': '2008-02-04', 'lastUpdatePostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-10', 'studyFirstPostDateStruct': {'date': '2008-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts', 'timeFrame': 'Day 0, 4, 7, 9, 11, and 14.', 'description': 'Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum.'}], 'secondaryOutcomes': [{'measure': 'Alanine Aminotransferase (ALT)', 'timeFrame': 'Day 0, 4, 7, 9, 11, and 14.', 'description': 'ALT was measured at Day 0, 4, 7, 9, 11, and 14.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acetaminophen', 'protein adducts', 'hepatic function', 'drug safety', 'non drinkers'], 'conditions': ['Drug Induced Liver Injury']}, 'descriptionModule': {'briefSummary': 'Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver. The protein-acetaminophen product is called an "adduct." After a large acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of adducts are formed. However, we have found that lower levels may be formed even when people take recommended doses. The purpose of this study is to measure the amount of adducts formed when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 21 years or older\n2. provide written informed consent\n3. consume, on average, less than 1 alcoholic beverage daily for the previous 3 months and would be considered non-drinkers\n\nExclusion Criteria:\n\n1. History of ingesting more than 4 grams of acetaminophen per day for any of the 4 days preceding study enrollment\n2. Currently taking isoniazid\n3. Consumption of any alcoholic beverage during the run-in period\n4. A detectable serum acetaminophen at baseline\n5. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 50 IU/L at the start of the run-in period or at baseline\n6. Platelet count less than 125,000/cc at baseline\n7. Positive pregnancy test at baseline (female participants only)\n8. Currently adheres to a fasting type diet as determined by self report\n9. Currently has anorexia nervosa as determined by self report\n10. Subject appears clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason\n11. Known hypersensitivity to acetaminophen'}, 'identificationModule': {'nctId': 'NCT00616018', 'acronym': 'Non-Drinker', 'briefTitle': 'Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days', 'organization': {'class': 'OTHER', 'fullName': 'Denver Health and Hospital Authority'}, 'officialTitle': 'Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days', 'orgStudyIdInfo': {'id': 'COMIRB #06-1187'}, 'secondaryIdInfos': [{'id': 'COMIRB #06-1187'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study', 'interventionNames': ['Drug: acetaminophen']}], 'interventions': [{'name': 'acetaminophen', 'type': 'DRUG', 'otherNames': ['Tylenol Extra Strength'], 'description': '4 g/day for 10 consecutive days', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health Rocky Mountain Poison and Drug Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Kennon Heard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Denver Health/Rocky Mountain Poison & Drug Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kennon Heard', 'class': 'OTHER'}, 'collaborators': [{'name': 'McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Toxicology Fellowship Director', 'investigatorFullName': 'Kennon Heard', 'investigatorAffiliation': 'Denver Health and Hospital Authority'}}}}