Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT01791400
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2013-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Metoclopramide Versus Sumatriptan for Emergency Department Treatment of Migraine Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'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': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D018170', 'term': 'Sumatriptan'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-13', 'studyFirstSubmitDate': '2013-02-10', 'studyFirstSubmitQcDate': '2013-02-13', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': 'at one hour after prescription', 'description': 'determining pain in Metoclopramide versus sumatriptan groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Metoclopramide', 'Sumatriptan', 'migraine', 'headache'], 'conditions': ['Migraine Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine which drug makes lower migraine headache', 'detailedDescription': 'There are different options to manage benign headache in emergency department.The investigators compared Intravenous metoclopramide with Subcutaneous sumatriptan to relieve pain in emergency department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-60 years old and presented with acute headache similar to previous episodes,\n* with or without phonophobia,\n* photophobia,\n* vomiting or nausea.\n\nExclusion Criteria:\n\n* fever or neck stiffness,\n* altered mental state,\n* pregnancy,\n* recent trauma or seizure (within 24 hours),\n* focal neurological abnormality on physical examination,\n* allergy to metoclopramide,\n* hypertension,\n* cardiovascular diseases.\n\nAlso if the patients had taken a triptan or ergot during the last 24 hours were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT01791400', 'briefTitle': 'Effect of Metoclopramide Versus Sumatriptan for Emergency Department Treatment of Migraine Headache', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Study of Effects of Metoclopramide Versus Sumatriptan on Migraine Headache', 'orgStudyIdInfo': {'id': 'ASD-1213-70'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'sumatriptan', 'description': 'Patients who underwent 6 mg sumatriptan subcutaneous one time', 'interventionNames': ['Drug: Sumatriptan, injection, 6 mg, one time']}, {'type': 'OTHER', 'label': 'Metoclopramide', 'description': 'Patients who underwent 20 mg Metoclopramide intravenous one time', 'interventionNames': ['Drug: metoclopramide, injection,20mg, one time']}], 'interventions': [{'name': 'metoclopramide, injection,20mg, one time', 'type': 'DRUG', 'otherNames': ['plasil'], 'description': 'metoclopramide, intravenous injection,20mg, one time', 'armGroupLabels': ['Metoclopramide']}, {'name': 'Sumatriptan, injection, 6 mg, one time', 'type': 'DRUG', 'description': 'Sumatriptan, subcutaneous injection, 6 mg, one time', 'armGroupLabels': ['sumatriptan']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'state': 'Isfahan', 'country': 'Iran', 'facility': 'Al-zahra university hospital', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'overallOfficials': [{'name': 'babak masoumi, A.Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isfahan, Isfahan, Iran, Islamic Republic of'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Hamidreza Shemshaki', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}