Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 9:08 PM
Study NCT ID:
NCT03503292
Status:
COMPLETED
Last Update Posted:
2020-10-28
First Post:
2018-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacogenomics and Post-Operative Nausea and Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017829', 'term': 'Granisetron'}, {'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'martin.yvette@mayo.edu', 'phone': '507-255-7481', 'title': 'Yvette N. Martin McGrew, M.D., Ph.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collect from baseline (surgery) to one week post surgery, for approximately one week.', 'eventGroups': [{'id': 'EG000', 'title': 'CYP2D6 Rapid Metabolizer (Granisetron)', 'description': 'Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment\n\nGranisetron: Rapid metabolizer received 1mg IV Granisetron', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CYP2D6 Normal Metabolizer (Ondansetron)', 'description': 'Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment\n\nOndansetron: Poor or normal metabolizers received 4mg Ondansetron IV', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 0, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Episodes of Postoperative Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYP2D6 Rapid Metabolizer (Granisetron)', 'description': 'Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment\n\nGranisetron: Rapid metabolizer received 1mg IV Granisetron'}, {'id': 'OG001', 'title': 'CYP2D6 Normal Metabolizer (Ondansetron)', 'description': 'Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment\n\nOndansetron: Poor or normal metabolizers received 4mg Ondansetron IV'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-48 hours post bariatric surgery', 'description': 'The total number count of post operative nausea episodes were determined by nursing documentation or by treatment with rescue antinausea medication.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Episodes of Postoperative Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYP2D6 Rapid Metabolizer (Granisetron)', 'description': 'Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment\n\nGranisetron: Rapid metabolizer received 1mg IV Granisetron'}, {'id': 'OG001', 'title': 'CYP2D6 Normal Metabolizer (Ondansetron)', 'description': 'Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment\n\nOndansetron: Poor or normal metabolizers received 4mg Ondansetron IV'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-48 hours post bariatric surgery', 'description': 'The total number count of post operative vomiting episodes were determined by nursing documentation or by treatment with rescue antinausea medication.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CYP2D6 Rapid Metabolizer (Granisetron)', 'description': 'Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment\n\nGranisetron: Rapid metabolizer received 1mg IV Granisetron'}, {'id': 'FG001', 'title': 'CYP2D6 Normal Metabolizer (Ondansetron)', 'description': 'Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment\n\nOndansetron: Poor or normal metabolizers received 4mg Ondansetron IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CYP2D6 Rapid Metabolizer (Granisetron)', 'description': 'Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment\n\nGranisetron: Rapid metabolizer received 1mg IV Granisetron'}, {'id': 'BG001', 'title': 'CYP2D6 Normal Metabolizer (Ondansetron)', 'description': 'Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment\n\nOndansetron: Poor or normal metabolizers received 4mg Ondansetron IV'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '21.2', 'groupId': 'BG000'}, {'value': '47.1', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '47.2', 'spread': '13.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'spread': '15.9', 'groupId': 'BG000'}, {'value': '45.4', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '45.4', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-20', 'size': 229378, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-02T15:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-04', 'studyFirstSubmitDate': '2018-04-03', 'resultsFirstSubmitDate': '2020-10-04', 'studyFirstSubmitQcDate': '2018-04-11', 'lastUpdatePostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-04', 'studyFirstPostDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Episodes of Postoperative Nausea', 'timeFrame': '0-48 hours post bariatric surgery', 'description': 'The total number count of post operative nausea episodes were determined by nursing documentation or by treatment with rescue antinausea medication.'}, {'measure': 'Episodes of Postoperative Vomiting', 'timeFrame': '0-48 hours post bariatric surgery', 'description': 'The total number count of post operative vomiting episodes were determined by nursing documentation or by treatment with rescue antinausea medication.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacogenetics', 'CYP2D6', 'Ondansetron', 'Granisetron', 'Bariatric surgery'], 'conditions': ['Postoperative Nausea']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The Researchers overall goal is to evaluate the benefit and utility of preemptive genotypic data to guide post-operative nausea and vomiting treatment in the bariatric surgical population. The hypothesis is that using genotypic variation in CYP2D6 to select the appropriate 5HT3 serotonin receptor antagonist to treat PONV will decrease rates of PONV in the bariatric surgical population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* A Mayo Clinic patient scheduled to undergo any bariatric surgical procedure, including Roux-en-Y gastric bypass, sleeve gastrectomy, or duodenal switch.\n* Patient age 18 or above.\n* Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures.\n* Patient is willing to engage in a medication adjustment as part of their clinical visit (when needed).\n\nExclusion Criteria\n\n* Patient with uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.\n* Patients that deny access to their medical records for research purposes will not be included in this study. Also any patient who will be unable to have genetic testing at minimum of 1 week prior to scheduled surgery or with allergies to ondansetron or granisetron.\n* Any patient with prior genetic testing that is readily available in the medical record will be excluded from this study.\n* Any patient that is pregnant'}, 'identificationModule': {'nctId': 'NCT03503292', 'briefTitle': 'Pharmacogenomics and Post-Operative Nausea and Vomiting', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Using Pharmacogenomics (PGx) Results to Guide Post-operative Nausea and Vomiting (PONV) Treatment Practices: A Pilot Study', 'orgStudyIdInfo': {'id': '17-011283'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CYP2D6 rapid metabolizer', 'description': 'Participants with CYP2D6 rapid metabolizer status will received granisetron for for post operative nausea and vomiting prophylaxis and treatment', 'interventionNames': ['Drug: Granisetron']}, {'type': 'EXPERIMENTAL', 'label': 'CYP2D6 normal metabolizer', 'description': 'Participants with CYP2D6 poor or normal metabolizer status will received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment', 'interventionNames': ['Drug: Ondansetron']}], 'interventions': [{'name': 'Granisetron', 'type': 'DRUG', 'otherNames': ['Kytril'], 'description': 'Rapid metabolizer will receive 1mg IV Granisetron', 'armGroupLabels': ['CYP2D6 rapid metabolizer']}, {'name': 'Ondansetron', 'type': 'DRUG', 'otherNames': ['Zofran'], 'description': 'Poor or normal metabolizers will receive 4mg Ondansetron IV', 'armGroupLabels': ['CYP2D6 normal metabolizer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Yvette N Martin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yvette N. Martin, MD-PhD', 'investigatorAffiliation': 'Mayo Clinic'}}}}