Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT00743093
Status:
COMPLETED
Last Update Posted:
2013-09-18
First Post:
2008-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Aminotransferase Trends During Prolonged Acetaminophen Dosing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, '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, PhD', 'organization': 'Denver Heatlh Rocky Mountain Poison and Drug Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was limited to healthy volunteers. The ingestion of each dose of study drug and use of other medications was self-reported.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected starting at the time of consent through study completion.', 'eventGroups': [{'id': 'EG000', 'title': 'Acetaminophen Arm', 'description': 'acetaminophen\n\nacetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days.', 'otherNumAtRisk': 224, 'otherNumAffected': 147, 'seriousNumAtRisk': 224, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Arm', 'description': 'placebo\n\nplacebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days', 'otherNumAtRisk': 52, 'otherNumAffected': 25, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear and labyrinth disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muskuloskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Proportion of Subjects Treated With Long-term Acetaminophen (4 g/Day) That Develops Persistent ALT Elevations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetaminophen Arm', 'description': 'acetaminophen\n\nacetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'placebo\n\nplacebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days'}], 'classes': [{'title': 'Subjects without persisitent ALT elevation', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with persistent ALT elevation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'serial samples for 16-40 days', 'description': 'ALT was measured on Day 0 and 16 for all study participants. Subjects with an elevated ALT at Day 16 continued dosing with study drug and continued to have their ALT measured every three days until the ALT elevation resolved or until Day 40. Persistent ALT elevation was defined as any subject with an unresolved ALT elevation at study Day 40.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total number of subjects completing the trial was used for analysis. Subjects who withdrew early were not included.'}, {'type': 'SECONDARY', 'title': 'The Proportion of Subjects With Detectable Serum Acetaminophen-cysteine Adduct (APAP-cys) Concentrations 1, 2, and 3 Days After Starting the Maximal Recommended Dosing of Acetaminophen (4 g/Day).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetaminophen Arm', 'description': 'acetaminophen\n\nacetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'placebo\n\nplacebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days'}], 'classes': [{'title': 'Day 1-No. Subjects with Detectable APAP-cys', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 2-No. Subjects with Detectable APAP-cys', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 3-No. Subjects with Detectable APAP-cys', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1-3', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of the safety population was monitored for early detection of APAP-cys. This subset of subjects had APAP-cys measured at Days 1, 2, and 3 in addition to other protocol defined timepoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acetaminophen Arm', 'description': 'acetaminophen\n\nacetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days.'}, {'id': 'FG001', 'title': 'Placebo Arm', 'description': 'placebo\n\nplacebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days'}], 'periods': [{'title': 'Base Study Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}, {'title': 'Extended Dosing Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Subjects not meeting stopping criteria after base continued into the extended dosing.', 'groupId': 'FG000', 'numSubjects': '51'}, {'comment': 'Subjects not meeting stopping criteria after base continued into the extended dosing.', 'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment took place from August 2008 through August 2011 in the Denver Metro area. Healthy volunteers were recruited from the community through the use of approved advertisements.', 'preAssignmentDetails': '398 subjects were consented for the study. Of these, 122 were excluded for not meeting full eligibility criteria. 276 eligible subjects were assigned to treatment groups, of which 252 completed all study requirements.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acetaminophen Arm', 'description': 'acetaminophen 500 mg'}, {'id': 'BG001', 'title': 'Placebo Arm', 'description': 'placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '12.16', 'groupId': 'BG000'}, {'value': '35.8', 'spread': '12.50', 'groupId': 'BG001'}, {'value': '36.2', 'spread': '12.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline characteristics were collected on all subjects at screening and included: race, ethnicity, gender, age, weight, and height. The number of participants included in the analysis (276) is based on the safety population, which includes any subject that took at least one dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-06', 'studyFirstSubmitDate': '2008-08-26', 'resultsFirstSubmitDate': '2013-03-18', 'studyFirstSubmitQcDate': '2008-08-27', 'lastUpdatePostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-19', 'studyFirstPostDateStruct': {'date': '2008-08-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Proportion of Subjects Treated With Long-term Acetaminophen (4 g/Day) That Develops Persistent ALT Elevations.', 'timeFrame': 'serial samples for 16-40 days', 'description': 'ALT was measured on Day 0 and 16 for all study participants. Subjects with an elevated ALT at Day 16 continued dosing with study drug and continued to have their ALT measured every three days until the ALT elevation resolved or until Day 40. Persistent ALT elevation was defined as any subject with an unresolved ALT elevation at study Day 40.'}], 'secondaryOutcomes': [{'measure': 'The Proportion of Subjects With Detectable Serum Acetaminophen-cysteine Adduct (APAP-cys) Concentrations 1, 2, and 3 Days After Starting the Maximal Recommended Dosing of Acetaminophen (4 g/Day).', 'timeFrame': 'Days 1-3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acetaminophen', 'protein adducts', 'drug safety', 'alanine aminotransferase', 'Alanine Amino Transferase'], 'conditions': ['Drug Toxicity', 'Healthy']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Drug Induced Liver Injury Network, U. S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry Drug Induced Liver Injury: Premarketing Clinical Evaluation [Web Page]. 2007 Oct; Accessed 2008 Jan 17. Available at: http://www.fda.gov/cder/guidance/index.htm.'}, {'pmid': '12546607', 'type': 'BACKGROUND', 'citation': 'Case JP, Baliunas AJ, Block JA. Lack of efficacy of acetaminophen in treating symptomatic knee osteoarthritis: a randomized, double-blind, placebo-controlled comparison trial with diclofenac sodium. Arch Intern Med. 2003 Jan 27;163(2):169-78. doi: 10.1001/archinte.163.2.169.'}, {'pmid': '16530510', 'type': 'BACKGROUND', 'citation': 'Davern TJ 2nd, James LP, Hinson JA, Polson J, Larson AM, Fontana RJ, Lalani E, Munoz S, Shakil AO, Lee WM; Acute Liver Failure Study Group. Measurement of serum acetaminophen-protein adducts in patients with acute liver failure. Gastroenterology. 2006 Mar;130(3):687-94. doi: 10.1053/j.gastro.2006.01.033.'}, {'pmid': '16316472', 'type': 'BACKGROUND', 'citation': 'Garcia Rodriguez LA, Gonzalez-Perez A. Long-term use of non-steroidal anti-inflammatory drugs and the risk of myocardial infarction in the general population. BMC Med. 2005 Nov 29;3:17. doi: 10.1186/1741-7015-3-17.'}, {'pmid': '14999359', 'type': 'BACKGROUND', 'citation': 'Golden HE, Moskowitz RW, Minic M. Analgesic efficacy and safety of nonprescription doses of naproxen sodium compared with acetaminophen in the treatment of osteoarthritis of the knee. Am J Ther. 2004 Mar-Apr;11(2):85-94. doi: 10.1097/00045391-200403000-00002.'}, {'pmid': '25047090', 'type': 'DERIVED', 'citation': 'Heard K, Green JL, Anderson V, Bucher-Bartelson B, Dart RC. A randomized, placebo-controlled trial to determine the course of aminotransferase elevation during prolonged acetaminophen administration. BMC Pharmacol Toxicol. 2014 Jul 22;15:39. doi: 10.1186/2050-6511-15-39.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to monitor liver function tests (blood levels of an indicator of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen compared to people taking placebo for 16 to 40 days. Those people that continue to have normal liver tests after 16 days will have completed their part of the study. People that develop abnormal liver function tests will continue taking acetaminophen or placebo, and have their liver tests monitored closely for up to an additional 24 days. This is to (1) make sure these tests return to normal and (2) determine when these tests return to normal while still taking acetaminophen or placebo. If at any time the liver tests indicate anything more than a minor increase, you would be immediately told to stop taking the study drug.\n\nSecondary objective is to determine the proportion of subjects that have detectable acetaminophen-protein adducts after daily dosing.', 'detailedDescription': 'Acetaminophen use is common and many consumers take 4g/day for longer than 4 days. The use of 4g/day of acetaminophen for more than 4 days causes an asymptomatic ALT elevation in some people. This elevation most likely resolves while continuing treatment, but it is possible that some individuals may go on to develop clinical liver injury. By carefully following healthy subjects who are taking the maximal daily dose of acetaminophen, we can safely determine if the ALT elevation resolves or progresses to clinical liver injury. If a subject develops clinical liver injury we can intervene before irreversible injury occurs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 or older\n\nExclusion Criteria:\n\n1. History of acetaminophen ingestion on any of the four days preceding study enrollment\n2. Measurable serum acetaminophen level at time of enrollment\n3. Viral markers of Hepatitis B or C, or viral markers of Hepatitis A with an ALT level greater than ULN during screening laboratory testing\n4. Serum ALT or AST level greater than ULN at Screening or Day 0\n5. Total bilirubin level greater than ULN at Screening or Day 0\n6. INR level greater than ULN at Screening\n7. Alkaline phosphatase level greater than ULN at Screening\n8. Platelet count less than 125 10\\^9/L at Screening\n9. Known cholelithiasis\n10. Positive pregnancy test at Screening (female participants only)\n11. History of consuming more than an average of 3 alcohol containing drinks daily over the preceding 2 weeks\n12. History of consuming 3 or more alcohol containing drinks on any given day during the 2 weeks prior to study enrollment\n13. New prescription medication started within the previous 30 days\n14. Currently taking isoniazid\n15. Currently taking warfarin\n16. Currently adheres to a fasting type diet as determined by self report\n17. Currently has anorexia nervosa as determined by self report\n18. Participant is clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason\n19. Known hypersensitivity or allergy to acetaminophen'}, 'identificationModule': {'nctId': 'NCT00743093', 'briefTitle': 'Aminotransferase Trends During Prolonged Acetaminophen Dosing', 'organization': {'class': 'OTHER', 'fullName': 'Denver Health and Hospital Authority'}, 'officialTitle': 'Aminotransferase Trends During Prolonged Therapeutic Acetaminophen Dosing', 'orgStudyIdInfo': {'id': 'COMIRB #06-1265'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acetaminophen', 'description': 'acetaminophen, 4 grams/day (1 gram every 4 hours for 4 doses)', 'interventionNames': ['Drug: acetaminophen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo for acetaminophen 4 grams/day (2 caplets every 4 hours for 4 doses)', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'acetaminophen', 'type': 'DRUG', 'otherNames': ['tylenol'], 'description': '500 mg caplets; 2 caplets (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days.', 'armGroupLabels': ['acetaminophen']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health Sciences Center - GCRC', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'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': 'Denver Health and Hospital Authority', 'class': 'OTHER'}, 'collaborators': [{'name': 'McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellowship Director', 'investigatorFullName': 'Kennon Heard', 'investigatorAffiliation': 'Denver Health and Hospital Authority'}}}}