Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT00944502
Status:
UNKNOWN
Last Update Posted:
2009-07-24
First Post:
2009-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-07-23', 'studyFirstSubmitDate': '2009-07-22', 'studyFirstSubmitQcDate': '2009-07-22', 'lastUpdatePostDateStruct': {'date': '2009-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observation of adverse events related to medication. The causality of adverse events concerning the use of medication will be given after applying the Naranjo Algorythm', 'timeFrame': 'Ten days'}], 'secondaryOutcomes': [{'measure': 'Efficacy evaluation Likert scale and Visual Analogue', 'timeFrame': 'Ten days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neuralgy', 'Dexamethasone', 'Complex Vitamins', 'Injection', 'Symptoms of neuralgy of various origins'], 'conditions': ['Neuralgia']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and tolerability of Vitatonus Dexa compared with dexamethasone in the signs and symptoms of neuralgia of various origins.\n\nClinical study, randomized prospective and random in nature, with a patients diagnosed with neuralgia of diverse origin.\n\nPatients will be include in sufficient quantity to achieve the minimum of 104 evaluable patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who consent to participate in the study by signing the ICF;\n2. Patients of any ethnic group of both sexs aged over 18 years;\n3. Patients with clinical diagnosis of neuralgia of various origins.\n4. Patients who present scores on the Visual Analogue Scale (VAS) greater than or equal to 4 for PAIN.\n\nExclusion Criteria:\n\n1. Patients with known hypersensitivity to lidocaine and thiamine or any component of the formula;\n2. Pregnant women and nursing mothers;\n3. Hypertensive or cardiac patients;\n4. Patients with history of ulcers in the stomach or duodenum, diabetes mellitus or severe infections;\n5. Patients who use levodopa, salicylates, colchicine, aminoglycosides, chloramphenicol, anticonvusivantes or potassium supplement.\n6. Patient with a history of alcohol or use illicit drugs;'}, 'identificationModule': {'nctId': 'NCT00944502', 'briefTitle': 'To Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bunker Industria Farmaceutica Ltda.'}, 'officialTitle': 'Multicenter Clinical Study, Phase III, Prospective, Randomized, Double-blind, Comparative to Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins', 'orgStudyIdInfo': {'id': 'E03-BUN-VITD-02/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexamethasone and complex vitamins', 'description': 'Group A: Vitatonus dexa injectable:\n\n1 ampoule intramuscularly every 3 days for 10 days.\n\nGroup B: Vitatonus DEXA tablet:\n\n1 tablet orally every 8 hours for 10 days.', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone', 'description': 'Group C: Dexamethasone Injectable:\n\n1 ampoule intramuscularly every 3 days for 10 days.\n\nGroup D: Dexamethasone tablet:\n\n1 tablet orally every 8 hours for 10 days.', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Vitatonus dexa tablest', 'Vitatonus Dexa Injectable'], 'description': 'Group A: Vitatonus DEXA injectable:\n\n1 ampoule intramuscularly every 3 days for 10 days.\n\nGroup B: Vitatonus DEXA tablets:\n\n1 tablet orally every 8 hours for 10 days.\n\nGroup C: Dexamethasone Injectable:\n\n1 ampoule intramuscularly every 3 days for 10 days.\n\nGroup D: Dexamethasone tablets:\n\n1 tablet orally every 8 hours for 10 days.', 'armGroupLabels': ['Dexamethasone', 'Dexamethasone and complex vitamins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09060650', 'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Rosa Hasan', 'role': 'CONTACT', 'email': 'r.hasan@terra.com.br', 'phone': '55 1149935469'}, {'name': 'Rosa Hasan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculdade de Medicina do ABC', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}], 'overallOfficials': [{'name': 'Rosa Hasan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculdade de Medicina do ABC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bunker Industria Farmaceutica Ltda.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Elaine Pessoa', 'oldOrganization': 'Bunker Indústria Farmacêutica Ltda.'}}}}