Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT05065567
Status:
TERMINATED
Last Update Posted:
2025-05-21
First Post:
2021-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'C536228', 'term': 'Familial cyclic vomiting syndrome'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004329', 'term': 'Droperidol'}, {'id': 'D006220', 'term': 'Haloperidol'}, {'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rachelle.pichot@corewellhealth.org', 'phone': '(240)389-7340', 'title': 'Research Specialist', 'organization': 'SpectrumLakeland'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Limitations: This study was terminated as the researchers were unable to enroll enough patients and too many patients were lost to follow up.'}}, 'adverseEventsModule': {'timeFrame': '48 hours from drug administration.', 'eventGroups': [{'id': 'EG000', 'title': 'Haloperidol', 'description': 'these patients will receive 5mg IM haloperidol\n\nHaloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Droperidol', 'description': 'these patients will receive 2.5mg IV droperidol\n\nDroperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ondansetron', 'description': 'these patients will receive 8mg IV ondansetron\n\nOndansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Abdominal Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Haloperidol', 'description': 'these patients will receive 5mg IM haloperidol\n\nHaloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM'}, {'id': 'OG001', 'title': 'Droperidol', 'description': 'these patients will receive 2.5mg IV droperidol\n\nDroperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV'}, {'id': 'OG002', 'title': 'Ondansetron', 'description': 'these patients will receive 8mg IV ondansetron\n\nOndansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '3.38', 'spread': '3.04', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '3.70', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours', 'description': 'change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Haloperidol', 'description': 'these patients will receive 5mg IM haloperidol\n\nHaloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM'}, {'id': 'OG001', 'title': 'Droperidol', 'description': 'these patients will receive 2.5mg IV droperidol\n\nDroperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV'}, {'id': 'OG002', 'title': 'Ondansetron', 'description': 'these patients will receive 8mg IV ondansetron\n\nOndansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron'}], 'classes': [{'categories': [{'measurements': [{'value': '3.40', 'spread': '3.37', 'groupId': 'OG000'}, {'value': '3.69', 'spread': '2.50', 'groupId': 'OG001'}, {'value': '5', 'spread': '4.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours', 'description': 'change in nausea on 0 (none) through 10 (worse possible nausea) on a scale', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Haloperidol', 'description': 'these patients will receive 5mg IM haloperidol\n\nHaloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM'}, {'id': 'OG001', 'title': 'Droperidol', 'description': 'these patients will receive 2.5mg IV droperidol\n\nDroperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV'}, {'id': 'OG002', 'title': 'Ondansetron', 'description': 'these patients will receive 8mg IV ondansetron\n\nOndansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours', 'description': 'both abdominal pain and nausea scores under 2 (none or minimal)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Abdominal Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Haloperidol', 'description': 'these patients will receive 5mg IM haloperidol\n\nHaloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM'}, {'id': 'OG001', 'title': 'Droperidol', 'description': 'these patients will receive 2.5mg IV droperidol\n\nDroperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV'}, {'id': 'OG002', 'title': 'Ondansetron', 'description': 'these patients will receive 8mg IV ondansetron\n\nOndansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': 'NA', 'comment': 'Only 1 pt; cannot calculate SD', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '3.71', 'groupId': 'OG001'}, {'value': '3', 'spread': 'NA', 'comment': 'Only 1 pt; cannot calculate SD', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Haloperidol', 'description': 'these patients will receive 5mg IM haloperidol\n\nHaloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM'}, {'id': 'OG001', 'title': 'Droperidol', 'description': 'these patients will receive 2.5mg IV droperidol\n\nDroperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV'}, {'id': 'OG002', 'title': 'Ondansetron', 'description': 'these patients will receive 8mg IV ondansetron\n\nOndansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': 'NA', 'comment': 'Only 1 pt; cannot calculate SD', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '3.67', 'groupId': 'OG001'}, {'value': '7.0', 'spread': 'NA', 'comment': 'Only 1 pt; cannot calculate SD', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'change in nausea on 0 (none) through 10 (worse possible nausea) on a scale', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Abdominal Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Haloperidol', 'description': 'these patients will receive 5mg IM haloperidol\n\nHaloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM'}, {'id': 'OG001', 'title': 'Droperidol', 'description': 'these patients will receive 2.5mg IV droperidol\n\nDroperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV'}, {'id': 'OG002', 'title': 'Ondansetron', 'description': 'these patients will receive 8mg IV ondansetron\n\nOndansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'Only 1 pt; cannot calculate SD', 'groupId': 'OG000'}, {'value': '3.69', 'spread': '4.10', 'groupId': 'OG001'}, {'value': '2', 'spread': 'NA', 'comment': 'Only 1 pt; cannot calculate SD', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Haloperidol', 'description': 'these patients will receive 5mg IM haloperidol\n\nHaloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM'}, {'id': 'OG001', 'title': 'Droperidol', 'description': 'these patients will receive 2.5mg IV droperidol\n\nDroperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV'}, {'id': 'OG002', 'title': 'Ondansetron', 'description': 'these patients will receive 8mg IV ondansetron\n\nOndansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': 'NA', 'comment': 'Only 1 pt; cannot calculate SD', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '3.42', 'groupId': 'OG001'}, {'value': '1', 'spread': 'NA', 'comment': 'Only 1 pt; cannot calculate SD', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'change in nausea on 0 (none) through 10 (worse possible nausea) on a scale', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Haloperidol', 'description': 'these patients will receive 5mg IM haloperidol\n\nHaloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM'}, {'id': 'OG001', 'title': 'Droperidol', 'description': 'these patients will receive 2.5mg IV droperidol\n\nDroperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV'}, {'id': 'OG002', 'title': 'Ondansetron', 'description': 'these patients will receive 8mg IV ondansetron\n\nOndansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'both abdominal pain and nausea scores under 2 (none or minimal)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Haloperidol', 'description': 'these patients will receive 5mg IM haloperidol\n\nHaloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM'}, {'id': 'OG001', 'title': 'Droperidol', 'description': 'these patients will receive 2.5mg IV droperidol\n\nDroperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV'}, {'id': 'OG002', 'title': 'Ondansetron', 'description': 'these patients will receive 8mg IV ondansetron\n\nOndansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours', 'description': 'both abdominal pain and nausea scores under 2 (none or minimal)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Haloperidol', 'description': 'these patients will receive 5mg IM haloperidol\n\nHaloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM'}, {'id': 'FG001', 'title': 'Droperidol', 'description': 'these patients will receive 2.5mg IV droperidol\n\nDroperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV'}, {'id': 'FG002', 'title': 'Ondansetron', 'description': 'these patients will receive 8mg IV ondansetron\n\nOndansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Haloperidol', 'description': 'these patients will receive 5mg IM haloperidol\n\nHaloperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM'}, {'id': 'BG001', 'title': 'Droperidol', 'description': 'these patients will receive 2.5mg IV droperidol\n\nDroperidol: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV'}, {'id': 'BG002', 'title': 'Ondansetron', 'description': 'these patients will receive 8mg IV ondansetron\n\nOndansetron 8mg: Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.45', 'spread': '8.56', 'groupId': 'BG000'}, {'value': '29.93', 'spread': '9.52', 'groupId': 'BG001'}, {'value': '27.57', 'spread': '9.52', 'groupId': 'BG002'}, {'value': '30.28', 'spread': '10.29', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pain_Before_Medication', 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'spread': '3.30', 'groupId': 'BG000'}, {'value': '3.38', 'spread': '3.04', 'groupId': 'BG001'}, {'value': '4.80', 'spread': '3.70', 'groupId': 'BG002'}, {'value': '3.86', 'spread': '3.17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale: 0 through 10', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nausea_Before_Medication', 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '3.37', 'groupId': 'BG000'}, {'value': '3.69', 'spread': '2.50', 'groupId': 'BG001'}, {'value': '5.00', 'spread': '4.10', 'groupId': 'BG002'}, {'value': '3.86', 'spread': '3.11', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale: 0 through 10', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-19', 'size': 191480, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-19T10:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'whyStopped': 'Lost too many patients to follow up, unable to enroll enough patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2021-09-23', 'resultsFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-19', 'studyFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal Pain', 'timeFrame': '2 hours', 'description': 'change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale'}, {'measure': 'Nausea', 'timeFrame': '2 hours', 'description': 'change in nausea on 0 (none) through 10 (worse possible nausea) on a scale'}, {'measure': 'Abdominal Pain', 'timeFrame': '24 hours', 'description': 'change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale'}, {'measure': 'Nausea', 'timeFrame': '24 hours', 'description': 'change in nausea on 0 (none) through 10 (worse possible nausea) on a scale'}, {'measure': 'Abdominal Pain', 'timeFrame': '48 hours', 'description': 'change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale'}, {'measure': 'Nausea', 'timeFrame': '48 hours', 'description': 'change in nausea on 0 (none) through 10 (worse possible nausea) on a scale'}], 'secondaryOutcomes': [{'measure': 'Treatment Success', 'timeFrame': '2 hours', 'description': 'both abdominal pain and nausea scores under 2 (none or minimal)'}, {'measure': 'Treatment Success', 'timeFrame': '24 hours', 'description': 'both abdominal pain and nausea scores under 2 (none or minimal)'}, {'measure': 'Treatment Success', 'timeFrame': '48 hours', 'description': 'both abdominal pain and nausea scores under 2 (none or minimal)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cyclic Vomiting Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two commonly used agents for the treatment of cyclic vomiting to see if one agent is inferior to the other in time to improvement in symptoms, need for repeat or rescue medications, treatment failures and complications/side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients with clinical diagnosis of cyclic vomiting in the ED\n\nExclusion Criteria:\n\n* pregnancy, allergy to any of the study medicines'}, 'identificationModule': {'nctId': 'NCT05065567', 'briefTitle': 'Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health South'}, 'officialTitle': 'A Comparison of Haloperidol 5mg IM vs Droperidol 2.5mg and Ondansetron for the Treatment of Hyperemesis in Cannabis Hyperemesis Syndrome', 'orgStudyIdInfo': {'id': 'EGME#02-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'haloperidol', 'description': 'these patients will receive 5mg IM haloperidol', 'interventionNames': ['Drug: Haloperidol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'droperidol', 'description': 'these patients will receive 2.5mg IV droperidol', 'interventionNames': ['Drug: Droperidol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ondansetron', 'description': 'these patients will receive 8mg IV ondansetron', 'interventionNames': ['Drug: Ondansetron 8mg']}], 'interventions': [{'name': 'Droperidol', 'type': 'DRUG', 'description': 'Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV', 'armGroupLabels': ['droperidol']}, {'name': 'Haloperidol', 'type': 'DRUG', 'description': 'Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM', 'armGroupLabels': ['haloperidol']}, {'name': 'Ondansetron 8mg', 'type': 'DRUG', 'description': 'Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron', 'armGroupLabels': ['ondansetron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49085', 'city': 'Saint Joseph', 'state': 'Michigan', 'country': 'United States', 'facility': 'Lakeland Regional Healthcare', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health South', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}