Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-09 @ 4:15 AM
Study NCT ID:
NCT01406860
Status:
TERMINATED
Last Update Posted:
2017-12-05
First Post:
2010-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003027', 'term': 'Cluster Headache'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D018781', 'term': 'Tension-Type Headache'}], 'ancestors': [{'id': 'D051303', 'term': 'Trigeminal Autonomic Cephalalgias'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D004329', 'term': 'Droperidol'}, {'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D004155', 'term': 'Diphenhydramine'}], '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': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brett-faine@uiowa.edu', 'phone': '3193108067', 'title': 'Brett Faine', 'organization': 'University of Iowa Hospitals and Clinics'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Droperidol', 'description': 'Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Metoclopramide', 'description': 'Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses.\n\nDiphenhydramine: Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Scale (Numerical Rating Scale for Pain)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Droperidol', 'description': 'Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes'}, {'id': 'OG001', 'title': 'Metoclopramide + Diphenhydramine', 'description': 'Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses.\n\nDiphenhydramine: Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.'}], 'timeFrame': 'Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)', 'description': 'Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Droperidol', 'description': 'Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes'}, {'id': 'OG001', 'title': 'Metoclopramide', 'description': 'Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.'}], 'timeFrame': 'Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': '24 Hour Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Droperidol', 'description': 'Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes'}, {'id': 'OG001', 'title': 'Metoclopramide', 'description': 'Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.'}], 'timeFrame': '24 hours after discharge from ED', 'description': '24 hour pain score (follow-up phone call)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Adverse Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Droperidol', 'description': 'Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes'}, {'id': 'OG001', 'title': 'Metoclopramide', 'description': 'Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.'}], 'timeFrame': 'From the time when the treatment is initiated until the 24 hour follow-up phone survey', 'description': 'Frequency of adverse effects in each arm', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Droperidol', 'description': 'Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes'}, {'id': 'FG001', 'title': 'Metoclopramide + Diphenhydramine', 'description': 'Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Droperidol', 'description': 'Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes'}, {'id': 'BG001', 'title': 'Metoclopramide + Diphenhydramine', 'description': 'Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses.\n\nDiphenhydramine: Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.6', 'spread': '9.01', 'groupId': 'BG000'}, {'value': '30.6', 'spread': '5.31', 'groupId': 'BG001'}, {'value': '32.6', 'spread': '7.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'lack of enrollment/drug shortages', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-27', 'studyFirstSubmitDate': '2010-09-22', 'resultsFirstSubmitDate': '2017-06-21', 'studyFirstSubmitQcDate': '2011-07-29', 'lastUpdatePostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-27', 'studyFirstPostDateStruct': {'date': '2011-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scale (Numerical Rating Scale for Pain)', 'timeFrame': 'Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)', 'description': 'Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain'}], 'secondaryOutcomes': [{'measure': 'Length of Stay', 'timeFrame': 'Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes)'}, {'measure': '24 Hour Pain Score', 'timeFrame': '24 hours after discharge from ED', 'description': '24 hour pain score (follow-up phone call)'}, {'measure': 'Adverse Effects', 'timeFrame': 'From the time when the treatment is initiated until the 24 hour follow-up phone survey', 'description': 'Frequency of adverse effects in each arm'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Headaches', 'Migraines', 'Tension headaches', 'Cluster headaches'], 'conditions': ['Primary Headaches (Includes Migraines, Tension, Cluster Headaches)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if droperidol is equally as effective as metoclopramide for treatment of primary headaches in the Emergency Department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old to 65 years old, diagnosis of primary headache\n\nExclusion Criteria:\n\n* Allergy to study medications, pregnant, breast-feeding, prisoners, non-english speaking, not eligible to receive droperidol based on ED protocol (see below), patients in whom head trauma, infection, vascular disorders, and disorders of facial or cranial structures are suspected\n\nED Droperidol Protocol\n\nDroperidol must NOT be used in patients with any of the following:\n\n* Known or suspected QT prolongation, including congenital long QT syndrome\n* Cardiac Disease \\[cardiomyopathy, congestive heart failure, hypertension, ischemic heart disease, myocardial infarction, bradycardia (\\< 50 bpm)\\]\n* History of the following:\n\n * Renal failure\n * Cerebrovascular disease\n * Diabetes or hypoglycemia\n * Alcoholism/alcohol abuse\n * Pituitary insufficiency\n * Hypothyroidism\n * Hypothermia\n * Anorexia\n* Advanced age (\\>65 yrs)\n* Use of the following medications: digoxin, benzodiazepine, diuretics, IV opiates, or other medications known to prolong the QTc interval.'}, 'identificationModule': {'nctId': 'NCT01406860', 'briefTitle': 'Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches in the Emergency Department: A Prospective Randomized, Double-blinded Trial.', 'orgStudyIdInfo': {'id': '201008798'}, 'secondaryIdInfos': [{'id': 'University of Iowa'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Droperidol', 'interventionNames': ['Drug: Droperidol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metoclopramide + Diphenhydramine', 'interventionNames': ['Drug: Metoclopramide + diphenhydramine']}], 'interventions': [{'name': 'Droperidol', 'type': 'DRUG', 'description': 'Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes', 'armGroupLabels': ['Droperidol']}, {'name': 'Metoclopramide + diphenhydramine', 'type': 'DRUG', 'description': 'Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.', 'armGroupLabels': ['Metoclopramide + Diphenhydramine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Jon Van Heukelom, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}, {'name': 'Christopher Hogrefe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}, {'name': 'Brett Faine, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacy Specialist', 'investigatorFullName': 'Brett A Faine', 'investigatorAffiliation': 'University of Iowa'}}}}