Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT04384367
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2020-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C093622', 'term': 'rizatriptan'}, {'id': 'D009288', 'term': 'Naproxen'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2068}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2020-05-11', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-hour pain-free', 'timeFrame': '11 weeks', 'description': '2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)'}], 'secondaryOutcomes': [{'measure': 'Most bothersome migraine-associated symptom', 'timeFrame': '11 weeks', 'description': 'Migraine-associated symptoms: nausea, vomiting, photophobia or phonophobia and phonophobia (frequency)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'A phase III study, multicenter, double-blind, double-dummy, randomized, single-dose, placebo-controlled study to evaluate the efficacy and safety of Rizatriptan-Naproxen (10/550 mg) in the acute treatment of migraine.\n\n⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).', 'detailedDescription': 'This is a prospective, randomized, double-blind, double-dummy and placebo-controlled study in individuals with disabling migraine. The participants will be randomized to receive Rizatriptan + Naproxen (10/550mg), Rizatriptan (10mg), Naproxen (550mg) or placebo.\n\n⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes;\n* Aged between 18 and 65 years old;\n* Capable and willing to give free and informed informed consent in writing;\n* Migraine patients with or without aura, according to the International Headache Society (IHS).\n\nExclusion Criteria:\n\n* Chronic migraine;\n* Headache other than migraine (that is, tension-type headache, sinusitis, etc.).'}, 'identificationModule': {'nctId': 'NCT04384367', 'acronym': 'RELIEF', 'briefTitle': 'Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eurofarma Laboratorios S.A.'}, 'officialTitle': 'A Multicenter, Double-blind, Double-dummy, Randomized, Single-dose, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine', 'orgStudyIdInfo': {'id': 'EF167'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rizatriptan 10mg+ Naproxen 550mg', 'description': 'Rizatriptan 10mg+ Naproxen 550mg', 'interventionNames': ['Drug: Rizatriptan 10 mg + Naproxen 550mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Maxalt 10mg', 'description': 'Rizatriptan10mg', 'interventionNames': ['Drug: Maxalt 10Mg Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flanax 550mg', 'description': 'Naproxen 550mg', 'interventionNames': ['Drug: Flanax 550mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Rizatriptan 10 mg + Naproxen 550mg', 'type': 'DRUG', 'otherNames': ['Medicamento'], 'description': 'oral - single dose', 'armGroupLabels': ['Rizatriptan 10mg+ Naproxen 550mg']}, {'name': 'Maxalt 10Mg Tablet', 'type': 'DRUG', 'otherNames': ['Medicamento'], 'description': 'oral - single dose', 'armGroupLabels': ['Maxalt 10mg']}, {'name': 'Flanax 550mg', 'type': 'DRUG', 'otherNames': ['Medicamento'], 'description': 'oral - single dose', 'armGroupLabels': ['Flanax 550mg']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'otherNames': ['Medicamento'], 'description': 'oral - single dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06696-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Eurofarma Laboratorios S.A', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'CEPIC', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eurofarma Laboratorios S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}