Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-05 @ 6:01 PM
Study NCT ID:
NCT04533568
Status:
COMPLETED
Last Update Posted:
2022-01-03
First Post:
2020-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ibuprofen in Migraine Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020326', 'term': 'Migraine without Aura'}], 'ancestors': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'C118296', 'term': 'dexketoprofen trometamol'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-12', 'studyFirstSubmitDate': '2020-08-22', 'studyFirstSubmitQcDate': '2020-08-28', 'lastUpdatePostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolving of Headache at 60 minute', 'timeFrame': '60 minutes after treatment - Change from Baseline Visual Analog Scale at 60th minutes', 'description': "Patients's headache scores will be measured by using Visual Analog Scale (VAS). This scale ranged from 0mm (no pain) to 100mm (worst pain). Measurements will be performed at pre-treatment period and 60th minute after treatments."}], 'secondaryOutcomes': [{'measure': 'Resolving of Headache at 30 minute', 'timeFrame': '30 minutes after treatment-Change from Baseline Visual Analog Scale at 30th minutes', 'description': "Patients's headache scores will be measured by using Visual Analog Scale (VAS). This scale ranged from 0mm (no pain) to 100mm (worst pain). Measurements will be performed at pre-treatment period and 30th minutes after treatments."}, {'measure': 'Needing of rescue treatment', 'timeFrame': '60 minutes after treatment', 'description': '60 minutes after treatment, as a rescue therapy, 100mg tramadol will be given to patients whose headache pain score - which measured by using Visual Analog Scale (VAS) - does not decrease by more than 50% from pretreatment-VAS score. This scale ranged from 0mm (no pain) to 100mm (worst pain).'}, {'measure': 'Side and adverse effects', 'timeFrame': 'From start of performing drug to in the first 24 hours after drug administration', 'description': 'any side/adverse effects related to study drugs such as hypotension, bradycardia, or anaphylaxis or local adverse effects such as pain or hematoma in the injection area'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['migraine without migraine', 'intravenous ibuprofen', 'intravenous dexketoprofen'], 'conditions': ['Migraine Without Aura']}, 'descriptionModule': {'briefSummary': "In this study, the investigators planned to compare the effectiveness of an intravenous ibuprofen against an intravenous dexketoprofen among patients (18-65 years) who were admitted to the emergency department (ED) with acute migraine-related headaches and diagnosed migraine without aura.\n\nIn this study, patients who presented with migraine-related headache to emergency departments will be included in this study. Two different therapy option are created; first, 400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl , second, 50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl.\n\nPatients's headache scores will be measured with visual analog score (VAS) at the pretreatment and post-treatment periods (0. minutes, 30. minutes, and 60. minutes.) 60 minutes after treatment, as a rescue therapy, 100mg tramadol will be given to patients whose headache score does not decrease by more than 50% from pretreatment-VAS score."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the patients aged 18-65 years who had been admitted to the ED for headaches and diagnosed acute migraine-related headache according to the International Classification of Headache Disorders-2018 edition\n* Patients whose pre-treatment VAS scores are more than 40 point.\n* Patients who give written and verbal consent to include study.\n\nExclusion Criteria:\n\n* Patients had taken any analgesic drugs or drugs for migraine prophylaxis in the last 6 hours\n* Patients had a history of allergy to any of the drugs used in this study\n* Patients used any anticoagulant-agents,\n* Patients had bleeding diathesis\n* patients were pregnant,\n* patients were breastfeeding mothers\n* Patients who had chronic heart disease, chronic liver disease, and chronic kidney disease\n* Patients had peptic ulcer\n* Patients had a history of acute akathisia or acute dystonia to metoclopramide hcl'}, 'identificationModule': {'nctId': 'NCT04533568', 'briefTitle': 'Ibuprofen in Migraine Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kecioren Education and Training Hospital'}, 'officialTitle': 'A Randomized-controlled Study; Comparison of the Effectiveness of Intravenous Ibuprofen and Intravenous Dexketoprofen in the Treatment of Migraine-related Headache in the Emergency Department', 'orgStudyIdInfo': {'id': '66175679'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ibuprofen', 'description': '400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.', 'interventionNames': ['Drug: Ibuprofen 400 mg']}, {'type': 'EXPERIMENTAL', 'label': 'dexketoprofen', 'description': '50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.', 'interventionNames': ['Drug: Dexketoprofen']}], 'interventions': [{'name': 'Ibuprofen 400 mg', 'type': 'DRUG', 'description': '400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.', 'armGroupLabels': ['ibuprofen']}, {'name': 'Dexketoprofen', 'type': 'DRUG', 'description': '50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.', 'armGroupLabels': ['dexketoprofen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Kecioren Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kecioren Education and Training Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'Şeref Kerem Çorbacıoğlu', 'investigatorAffiliation': 'Kecioren Education and Training Hospital'}}}}