Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-28 @ 4:01 AM
Study NCT ID:
NCT01181492
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2010-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ourpain@163.com', 'phone': '027 83662853', 'title': 'Zhang Xianwei', 'organization': 'Huazhong University of Science&Technology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The preoperative and postoperative data were not all integrallty recorded in a relative short period and entered into Excel.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '*1/*1', 'description': 'Grouped by CYP3A4\\*1G polymorphism, wild-type homozygote', 'otherNumAtRisk': 103, 'otherNumAffected': 0, 'seriousNumAtRisk': 103, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '*1/*1G', 'description': 'Grouped by CYP3A4\\*1G polymorphism,\\*1/\\*1G: mutant heterozygote', 'otherNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '*1G/*1G', 'description': 'Grouped by CYP3A4\\*1G polymorphism,\\*1G/\\*1G: mutant homozygote', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CYP3A4*1G Polymorphism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '*1/*1', 'description': 'Grouped by CYP3A4\\*1G polymorphism, wild-type homozygote'}, {'id': 'OG001', 'title': '*1/*1G', 'description': 'Grouped by CYP3A4\\*1G polymorphism,\\*1/\\*1G: mutant heterozygote'}, {'id': 'OG002', 'title': '*1G/*1G', 'description': 'Grouped by CYP3A4\\*1G polymorphism,\\*1G/\\*1G: mutant homozygote'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 hours after operation', 'description': 'According to CYP3A4\\*1G polymorphism,patients are devided into three groups: \\*1/\\*1,\\*1/\\*1G,\\*1G/\\*1G', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'the number of participants for analysis was determined according to gene type of CYP3A4\\*1G polymorphism which was carried by participant.'}, {'type': 'SECONDARY', 'title': 'The Visual Analog Scale 24 Hours Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '*1/*1', 'description': 'Grouped by CYP3A4\\*1G polymorphism, wild-type homozygote'}, {'id': 'OG001', 'title': '*1/*1G', 'description': 'Grouped by CYP3A4\\*1G polymorphism,\\*1/\\*1G: mutant heterozygote'}, {'id': 'OG002', 'title': '*1G/*1G', 'description': 'Grouped by CYP3A4\\*1G polymorphism,\\*1G/\\*1G: mutant homozygote'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours after operation', 'description': 'The visual analog scale (VAS) is used for pain evaluation at rest which from 0 to 10 (higher values represent morepain) during patient-controlled analgesia (PCA) treatment 24 h after operation', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PCA Fentanyl Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '*1/*1', 'description': 'Grouped by CYP3A4\\*1G polymorphism, wild-type homozygote'}, {'id': 'OG001', 'title': '*1/*1G', 'description': 'Grouped by CYP3A4\\*1G polymorphism,\\*1/\\*1G: mutant heterozygote'}, {'id': 'OG002', 'title': '*1G/*1G', 'description': 'Grouped by CYP3A4\\*1G polymorphism,\\*1G/\\*1G: mutant homozygote'}], 'classes': [{'categories': [{'measurements': [{'value': '395.0', 'spread': '138.5', 'groupId': 'OG000'}, {'value': '359.8', 'spread': '120.2', 'groupId': 'OG001'}, {'value': '247.1', 'spread': '73.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 h after surgery', 'description': 'PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.', 'unitOfMeasure': 'μg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '*1/*1', 'description': 'Grouped by CYP3A4\\*1G polymorphism, wild-type homozygote'}, {'id': 'FG001', 'title': '*1/*1G', 'description': 'Grouped by CYP3A4\\*1G polymorphism,\\*1/\\*1G: mutant heterozygote'}, {'id': 'FG002', 'title': '*1G/*1G', 'description': 'Grouped by CYP3A4\\*1G polymorphism,\\*1G/\\*1G: mutant homozygote'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'In Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, from November 2008 to April 2010 a total of 176 patients were recruited in this study precedure.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '*1/*1', 'description': 'Grouped by CYP3A4\\*1G polymorphism, wild-type homozygote'}, {'id': 'BG001', 'title': '*1/*1G', 'description': 'Grouped by CYP3A4\\*1G polymorphism,\\*1/\\*1G: mutant heterozygote'}, {'id': 'BG002', 'title': '*1G/*1G', 'description': 'Grouped by CYP3A4\\*1G polymorphism,\\*1G/\\*1G: mutant homozygote'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '47.1', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '42.3', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '45.9', 'spread': '11.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '176 blood samples were extracted'}, 'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-28', 'studyFirstSubmitDate': '2010-08-11', 'resultsFirstSubmitDate': '2012-12-04', 'studyFirstSubmitQcDate': '2010-08-12', 'lastUpdatePostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-08-28', 'studyFirstPostDateStruct': {'date': '2010-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CYP3A4*1G Polymorphism', 'timeFrame': '48 hours after operation', 'description': 'According to CYP3A4\\*1G polymorphism,patients are devided into three groups: \\*1/\\*1,\\*1/\\*1G,\\*1G/\\*1G'}], 'secondaryOutcomes': [{'measure': 'The Visual Analog Scale 24 Hours Postoperative', 'timeFrame': '24 hours after operation', 'description': 'The visual analog scale (VAS) is used for pain evaluation at rest which from 0 to 10 (higher values represent morepain) during patient-controlled analgesia (PCA) treatment 24 h after operation'}, {'measure': 'PCA Fentanyl Consumption', 'timeFrame': '24 h after surgery', 'description': 'PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gene polymorphism', 'CYP3A4', 'fentanyl', 'HPLC', 'Analgesics'], 'conditions': ['Pain', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Purpose: This study aimed to investigate the impact of CYP3A4\\*1G genetic polymorphism on metabolism of fentanyl in Chinese patients undergoing lower abdominal surgery. Methods: 176 patients receiving elective lower abdominal surgery under general anesthesia were recruited into this study. Genotyping of CYP3A4\\*1G was carried out by direct sequencing. The plasma fentanyl concentration was detected 30 min after anesthesia induction by high performance liquid chromatography-ultraviolet ray (HPLC-UV). The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h and 24 h after operation. PCA fentanyl consumption and adverse effects were recorded during the first 24 h after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '176 Chinese patients receiving elective lower abdominal surgery under general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 20-65 years\n* Anesthesiologists (ASA) physical status I or II;\n* With ±20% of ideal body weight;\n* Received PCA administration;\n* Agreed to participate the research\n\nExclusion Criteria:\n\n* History of chronic pain;\n* Psychiatric diseases;\n* Diabetes mellitus;\n* Severe cardiovascular diseases;\n* Kidney or liver diseases;\n* Alcohol or drug abuse (according to the criteria of DSM-IV);\n* Pregnancy or at lactation period;\n* Consumed drugs (1week) or foods (3 days) known to inhibit or induce the expression of CYP3A4 enzymes prior to surgery;\n* Refused PCA administration;\n* Disagree to participate to the research'}, 'identificationModule': {'nctId': 'NCT01181492', 'briefTitle': 'Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery', 'orgStudyIdInfo': {'id': 'HuazhongU'}}, 'armsInterventionsModule': {'armGroups': [{'label': '*1/*1', 'description': 'Grouped by CYP3A4\\*1G polymorphism, wild-type homozygote'}, {'label': '*1/*1G', 'description': 'Grouped by CYP3A4\\*1G polymorphism,\\*1/\\*1G: mutant heterozygote'}, {'label': '*1G/*1G', 'description': 'Grouped by CYP3A4\\*1G polymorphism,\\*1G/\\*1G: mutant homozygote'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': '1. Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Zhang Xianwei, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Tongji Hospital, Tongji Medical College', 'investigatorFullName': 'Xianwei Zhang', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}