Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT01408069
Status:
WITHDRAWN
Last Update Posted:
2021-02-24
First Post:
2011-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}, {'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study canceled by decision strategically.', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2011-08-01', 'studyFirstSubmitQcDate': '2011-08-02', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of treatment in relieve headache symptoms.', 'timeFrame': '1 hour', 'description': 'The evaluation of efficacy will be determined based on comparison of the intensity of headache before and after 30, 60 and 90 minutes of initiation of treatment.'}], 'secondaryOutcomes': [{'measure': 'Tolerability of study treatment', 'timeFrame': '56 days', 'description': 'Tolerability will be assessed by the investigator through the number of adverse events definitely related to study medication. This relationship will be defined by applying the Naranjo algorithm.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['headache', 'migraine'], 'conditions': ['Tensional-type Headache']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different associations of drugs in the treatment of patients diagnosed with tensional-type headache in accordance with International Headache Society guidelines.', 'detailedDescription': '* Open-label, non-inferiority, prospective, parallel group, intent to treat trial.\n* Experiment duration: 56 days.\n* 04 visits (days -7, 0, 28 and 56).\n* Efficacy will be evaluated for 10 episodes of tension-type headache.\n* Adverse events evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must be able to understand the study procedures agree to participate and give written consent.\n2. Tensional-type headache patients according to the International Headache Society criteria.\n3. Corporal body indices \\< 40.\n\nExclusion Criteria:\n\n1. Pregnancy or risk of pregnancy.\n2. Lactation\n3. Use of acetylsalicylic acid or corticosteroids or immunosuppressive therapy.\n4. Use of immunosuppressive drugs.\n5. Alterations of laboratory selective tests.\n6. Drugs or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT01408069', 'briefTitle': 'Non-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia', 'orgStudyIdInfo': {'id': 'ACHEMS0211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MIGRANE', 'description': '1 to 2 tablets ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg', 'interventionNames': ['Drug: MIGRANE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PARCEL', 'description': '1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)', 'interventionNames': ['Drug: PARCEL']}], 'interventions': [{'name': 'MIGRANE', 'type': 'DRUG', 'description': '1 to 2 tablets(ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg)', 'armGroupLabels': ['MIGRANE']}, {'name': 'PARCEL', 'type': 'DRUG', 'description': '1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)', 'armGroupLabels': ['PARCEL']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}