Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
Study NCT ID:
NCT06786650
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2024-11-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparision of the Analgesic Effects of Intravenous Ibuprofen and Tenoxicam in Acute Migraine Attack
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-16', 'releaseDate': '2025-06-30'}], 'estimatedResultsFirstSubmitDate': '2025-06-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C032801', 'term': 'tenoxicam'}, {'id': 'D007052', 'term': 'Ibuprofen'}], '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Medical treatments will be administered in 100 cc saline to ensure blindness in both treatment groups. The treatment will be prepared by the responsible investigator and will be numbered with the number on the sealed envelope. Thus, it will be ensured that the administering personnel and the patient will be blinded to the treatment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-21', 'studyFirstSubmitDate': '2024-11-29', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achievement of pain palliation', 'timeFrame': 'NRS scores of both patient groups will be recorded at the time of admission (NRS Baseline) and at 30, 60 and 120 minutes after the treatment is given.', 'description': 'The primary outcome of our study is the achievement of pain palliation. This will be defined as a ≥ 50% reduction in Numerical rating scale (NRS) scores after treatment compared to the baseline score (NRS Baseline). The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Mean and proportional reduction in NRS scores will also be analysed while evaluating the efficacy of the treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anti-Inflammatory Agents Non-Steroidal', 'Acute migrane attack'], 'conditions': ['Migraine', 'Analgesic Affect', 'Emergency Medicine']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to compare the efficacy of two different non-steroidal anti-inflammatory analgesic drugs in the palliation of headache in acute migraine attack. The main questions it aims to answer are:\n\n1. Is there a difference between the efficacy of two different nonsteroidal anti-inflammatory analgesics?\n2. Is there a significant difference between the side effects of two different nonsteroidal anti-inflammatory drugs? Researchers will compare intravenous tenoxicam to intravenous ibuprofen to see if tenoxicam works to treat migraine attack.\n\nTreatments will;\n\n1. be administered in 100 cc saline to ensure blinding in the group.\n2. Randomisation will be done by closed envelope method.\n3. Numerical Pain Scale (NRS) will be used to evaluate the analgesic efficacy of the drugs. NRS scores will be recorded in both groups before starting treatment (baseline) and at 30, 60 and 120 minutes after treatment.\n4. Any side effects due to medication will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 18-65.\n* Having a known diagnosis of migraine.\n* Exclusion of secondary causes to explain the headache in the emergency department.\n* Having migraine during a migraine attack and not having received any medical treatment for migraine before the application.\n\nExclusion Criteria:\n\n* Being under 18 years of age.\n* Being pregnant or breastfeeding.\n* Being admitted to the emergency department with headache due to causes other than migraine (secondary).\n* Being admitted with an acute migraine attack and having used medication for migraine treatment within 12 hours before admission.\n* Having a history of allergy to any of the drugs to be used in the study.\n* Having a history of comorbidities for which the drugs to be used in the study are contraindicated.'}, 'identificationModule': {'nctId': 'NCT06786650', 'briefTitle': 'Comparision of the Analgesic Effects of Intravenous Ibuprofen and Tenoxicam in Acute Migraine Attack', 'organization': {'class': 'OTHER', 'fullName': 'Haydarpasa Numune Training and Research Hospital'}, 'officialTitle': 'Comparision of the Analgesic Effects of Intravenous Ibuprofen and Tenoxicam in Acute Migraine Attack', 'orgStudyIdInfo': {'id': '2024-KAEK-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tenoxicam Group. IV Tenoxicam', 'description': 'Intravenous tenoxicam (20 mg) will be administered in 100 cc saline in 10 minutes to patients admitted to our emergency department with headache due to acute migraine attack.', 'interventionNames': ['Drug: Tenoxicam Injectable Product']}, {'type': 'SHAM_COMPARATOR', 'label': 'Ibuprofen Group. IV Ibuprofen', 'description': 'Intravenous ibuprofen (400 mg) will be administered in 100 cc saline in 10 minutes to patients who present to our emergency department due to headache due to acute migraine attack.', 'interventionNames': ['Drug: ibuprofen']}], 'interventions': [{'name': 'Tenoxicam Injectable Product', 'type': 'DRUG', 'otherNames': ['tenoxicam'], 'description': 'Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before.', 'armGroupLabels': ['Tenoxicam Group. IV Tenoxicam']}, {'name': 'ibuprofen', 'type': 'DRUG', 'description': 'Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before.', 'armGroupLabels': ['Ibuprofen Group. IV Ibuprofen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34843', 'city': 'Istanbul', 'state': 'Uskudar', 'country': 'Turkey (Türkiye)', 'facility': 'Haydarpasa Numune Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Colak, Professor Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'ICF', 'CSR'], 'timeFrame': '12 months ( 01.01.2025-01.01.2026)', 'ipdSharing': 'YES', 'description': 'all collected IPD, all IPD that underlie results in a publication', 'accessCriteria': 'The researcher responsible for data analysis will be authorised to access IPD for 1 year.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haydarpasa Numune Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Doctor', 'investigatorFullName': 'Sinem Dogruyol', 'investigatorAffiliation': 'Haydarpasa Numune Training and Research Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-06-30', 'type': 'RELEASE'}, {'date': '2025-07-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sinem Dogruyol, Associate Professor Doctor, Haydarpasa Numune Training and Research Hospital'}}}}