Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-22 @ 2:43 AM
Study NCT ID:
NCT02314351
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2014-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D020325', 'term': 'Migraine with Aura'}, {'id': 'D020326', 'term': 'Migraine without Aura'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D004630', 'term': 'Emergencies'}], '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': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D005283', 'term': 'Fentanyl'}], '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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-03', 'studyFirstSubmitDate': '2014-12-05', 'studyFirstSubmitQcDate': '2014-12-08', 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference between pain scores for both drugs', 'timeFrame': '15th and 30th minutes', 'description': 'The difference between pain scores (10- point numeric rating scale score) for metoclopramide and placebo groups'}], 'secondaryOutcomes': [{'measure': 'Nausea and vomiting', 'timeFrame': '30th minute', 'description': 'Change in nausea/vomiting status of the participants'}, {'measure': 'Adverse reactions', 'timeFrame': '30th minute', 'description': 'Number of participants with adverse events'}, {'measure': 'Need for rescue analgesic', 'timeFrame': '30th minute', 'description': 'Number of patients needed rescue analgesic at 30th minute'}, {'measure': 'Change in the headache intensity', 'timeFrame': 'Between 24th and 72th hours', 'description': 'Change in the headache intensity'}, {'measure': 'Duplicative presentation to the emergency department', 'timeFrame': 'Between 24th and 72th hours', 'description': 'With telephone call'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['migraine disorders', 'migraine with aura', 'migraine without aura', 'pain management', 'emergency department'], 'conditions': ['Migraine Disorders']}, 'descriptionModule': {'briefSummary': 'Migraine attacks were frequently diagnosed in the emergency departments. Also intravenous metoclopramide was a commonly used drug in the acute abortive treatment of migraine. However, the role of metoclopramide was based on three randomized, placebo-controlled studies, which were carried out with relatively few patients. Those trials suggested that metoclopramide produced larger improvements in visual analog scale (VAS) scores, however they revealed conflicting results and had significant methodological problems (risk of bias, allocation of concealment, intention-to-treat analysis). The investigators aimed to analyse the effects of intravenous metoclopramide in acute migraine attacks comparing with placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting to the emergency department with migraine attack (with aura or without aura, according to International Headache Society criteria, 2013)\n* The patients older than 18 years\n* Patients who agree to participate to the study by reading and signing the informed consent document\n\nExclusion Criteria:\n\n* The patients younger than 18 years\n* Pregnants\n* Patients taking any analgesic drugs last 2 hours\n* Documented or declared allergy to metoclopramide\n* Patients who are hemodynamically unstable\n* Patients who do not agree to participate to the study'}, 'identificationModule': {'nctId': 'NCT02314351', 'briefTitle': 'Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'KOU KAEK 2014/315'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous metoclopramide', 'description': 'Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL)', 'interventionNames': ['Drug: Metoclopramide 10 mg', 'Drug: Placebo', 'Drug: Fentanyl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.9% normal saline solution (total 100 mL)', 'interventionNames': ['Drug: Metoclopramide 10 mg', 'Drug: Placebo', 'Drug: Fentanyl']}], 'interventions': [{'name': 'Metoclopramide 10 mg', 'type': 'DRUG', 'otherNames': ['Metoclopramide 10 mg (2 mL) in 100 mL normal saline'], 'description': 'Intravenous form of metoclopramide is in the same appearance with placebo', 'armGroupLabels': ['Intravenous metoclopramide', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['100 mL normal saline'], 'description': 'Intravenous form of metoclopramide is in the same appearance with placebo', 'armGroupLabels': ['Intravenous metoclopramide', 'Placebo']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Intravenous fentanyl'], 'description': 'Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute', 'armGroupLabels': ['Intravenous metoclopramide', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41000', 'city': 'Köseköy', 'state': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University, Faculty of Medicine', 'geoPoint': {'lat': 40.74012, 'lon': 30.00556}}], 'overallOfficials': [{'name': 'Nurettin Özgür Doğan, Assoc. Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kocaeli University, Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Associate Professor', 'investigatorFullName': 'Nurettin Özgür Doğan', 'investigatorAffiliation': 'Kocaeli University'}}}}