Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-02-11 @ 12:16 AM
Study NCT ID:
NCT01755169
Status:
TERMINATED
Last Update Posted:
2017-01-23
First Post:
2012-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ketamine in Chronic Kid's (KiCK) Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bredlau@musc.edu', 'phone': '843-876-0444', 'title': 'Dr. Amy-Lee Bredlau', 'organization': 'MUSC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ketamine 0.25 mg/kg/Dose', 'description': 'A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.\n\nKetamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ketamine 0.5 mg/kg/Dose', 'description': 'A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.\n\nKetamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ketamine 1 mg/kg/Dose', 'description': 'A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.\n\nKetamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose Limiting Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine 0.25 mg/kg/Dose', 'description': 'A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.\n\nKetamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).'}, {'id': 'OG001', 'title': 'Ketamine 0.5 mg/kg/Dose', 'description': 'A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.\n\nKetamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).'}, {'id': 'OG002', 'title': 'Ketamine 1 mg/kg/Dose', 'description': 'A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.\n\nKetamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks', 'description': 'A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketamine 0.25 mg/kg/Dose', 'description': 'A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.\n\nKetamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).'}, {'id': 'FG001', 'title': 'Ketamine 0.5 mg/kg/Dose', 'description': 'A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.\n\nKetamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).'}, {'id': 'FG002', 'title': 'Ketamine 1 mg/kg/Dose', 'description': 'A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.\n\nKetamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketamine 0.25 mg/kg/Dose', 'description': 'A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.\n\nKetamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).'}, {'id': 'BG001', 'title': 'Ketamine 0.5 mg/kg/Dose', 'description': 'A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.\n\nKetamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).'}, {'id': 'BG002', 'title': 'Ketamine 1 mg/kg/Dose', 'description': 'A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.\n\nKetamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '8-20 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Inability to enroll sufficient patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-28', 'studyFirstSubmitDate': '2012-12-18', 'resultsFirstSubmitDate': '2016-11-28', 'studyFirstSubmitQcDate': '2012-12-21', 'lastUpdatePostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-28', 'studyFirstPostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose Limiting Toxicity', 'timeFrame': '2 weeks', 'description': 'A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic pain', 'Child', 'Pediatric', 'Ketamine'], 'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This study is designed to select the most tolerable dose of oral ketamine for children with chronic pain. Children will be given either placebo or one of three dosages of oral ketamine for 2 weeks. The dosage that is most tolerable will be selected for further study.', 'detailedDescription': 'Children with chronic pain are randomized to one of four arms (three study drug arms, one placebo arm) in a randomized, double-blinded fashion. Children are treated for 2 weeks and then monitored for an additional 12 weeks. Study participation is a total of 14 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject, parent, or guardian willing and able to give informed consent\n* NRS for pain over the past 24 hours \\>4 at baseline\n* Chronic pain, which has been present for \\>3 months, or persisting longer than is normal for the underlying diagnosis\n* Chronic pain related to physiologic diagnoses including but not limited to: cancer, rheumatologic disease, sickle cell anemia, cystic fibrosis, pancreatitis, and neuromuscular disease (e.g. Duchenne muscular dystrophy)\n* Able to tolerate and cooperate with neurocognitive assessment\n* Age 8-20 years old\n\nExclusion Criteria:\n\n* If they are known or suspected to have drug addiction\n* Uncontrolled psychiatric disorder such as depression, schizophrenia, or bipolar disorder\n* Uncontrolled hypertension\n* Known liver disease or elevation of AST or ALT greater than 3 times the upper limit of normal.\n* Previous intolerance or allergic reaction to ketamine\n* Pregnancy\n* Use of CYP3A4 inhibitors or inducers within the 2-week period prior the study drug administration or within 5 half-lives of the respective medication, whichever is longer, until study conclusion.\n* Consumption of grapefruit or grapefruit products from at least 2 weeks prior to study drug administration until study conclusion.'}, 'identificationModule': {'nctId': 'NCT01755169', 'acronym': 'KiCK Pain', 'briefTitle': "Ketamine in Chronic Kid's (KiCK) Pain", 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': "Ketamine in Chronic Kid's (KiCK) Pain", 'orgStudyIdInfo': {'id': 'KiCK Pain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine 0.25 mg/kg/dose', 'description': 'A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.', 'interventionNames': ['Drug: Ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'Ketamine 0.5 mg/kg/dose', 'description': 'A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.', 'interventionNames': ['Drug: Ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'Ketamine 1 mg/kg/dose', 'description': 'A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.', 'interventionNames': ['Drug: Ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['Ketalar'], 'description': 'Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).', 'armGroupLabels': ['Ketamine 0.25 mg/kg/dose', 'Ketamine 0.5 mg/kg/dose', 'Ketamine 1 mg/kg/dose']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Amy-Lee Bredlau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only aggregate data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Pediatric Brain Tumor Program', 'investigatorFullName': 'Amy-Lee Bredlau', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}