Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT00970658
Status:
UNKNOWN
Last Update Posted:
2009-09-04
First Post:
2009-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Salonsip Compared to Sabiá Plaster
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003288', 'term': 'Contusions'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D063806', 'term': 'Myalgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2010-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-09-03', 'studyFirstSubmitDate': '2009-09-01', 'studyFirstSubmitQcDate': '2009-09-01', 'lastUpdatePostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Likert Scales and Visual Analogue Scales', 'timeFrame': 'two days'}], 'secondaryOutcomes': [{'measure': 'Safety evaluation by adverse events relate.', 'timeFrame': 'two days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Plaster', 'injuries', 'regions miofasciais articulated', 'Reducing signs, symptoms'], 'conditions': ['Contusions', 'Sprains', 'Myalgia', 'Pain', 'Tendonitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy in reducing signs and symptoms in patients with contusions, sprains, muscular injuries and injuries with less than 24 hours early or holders of myalgia, pain and tendonitis in regions miofasciais articulated with Salonsip compared to Sabiá plaster.\n\nIt is clinical, open, multicenter, randomized, prospective and comparative, with patients entering at random.\n\nPatients will be included in sufficient quantity to achieve the minimum number of 70 evaluable patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes, of any race, aged 12 years;\n* Ability to read, understand and sign the Consent Form, in the case of children under age monitoring and consent of the person responsible;\n* Clinical diagnosis of bruises, sprains, trauma, muscle damage occurring in times less than 24 hours or myalgia, pain miofasciais or tendonitis.\n* Patients able to understand and maintain the clinical protocol\n\nExclusion Criteria:\n\n* Known hypersensitivity to components of the formulas of both the product and the comparative test.\n* Known hypersensitivity to paracetamol.\n* Location of the lesion with skin wound or irritated.\n* Hepatic or renal diseases known.\n* Pregnant or breastfeeding.\n* Patients who require surgery or immobilization rigid;\n* Patients with fractures or rupture of the ligaments.\n* Patients in use of anticoagulants.\n* Patients with severe concomitant systemic diseases such as cancer, diabetes, congenital or acquired heart disease, hematological diseases, convulsive disorders, autoimmune diseases, renal failure, infections, hormonal disorders and pulmonary disorders.\n* History of alcoholism or use of illicit drugs;\n* Use of non-steroidal anti-inflammatory drugs, corticosteroids or venoterápicos, topics or any other form of administration.\n* Conditions which in the opinion of the investigator makes the patient unsuitable to participate in the study.'}, 'identificationModule': {'nctId': 'NCT00970658', 'acronym': 'SAL-SIP-03/09', 'briefTitle': 'Efficacy and Safety of Salonsip Compared to Sabiá Plaster', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hisamitsu Farmaceutica do Brasil Ltda'}, 'officialTitle': 'Clinical Multicenter Study, Randomized, Open, to Evaluate the Efficacy and Safety of Salonsip Compared to Sabiá Plaster Relief of the Signs and Symptoms in Patients With Contusions, Sprains, Injuries and Muscular Injuries With Less Than 24 Hours Early or Holders of Myalgia, Pain and Tendonitis in Regions Miofasciais Articulated.', 'orgStudyIdInfo': {'id': 'SAL-SIP-03/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Salonsip', 'description': 'The plaster should be applied at the site of injury, which must be clean and dry and changed every 8 hours for a period of 48 hours of treatment (2 days).', 'interventionNames': ['Drug: Salonsip plaster']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sabiá', 'description': 'The plaster should be applied at the site of injury, which must be clean and dry and changed every 8 hours for a period of 48 hours of treatment (2 days).', 'interventionNames': ['Drug: Sabia plaster']}], 'interventions': [{'name': 'Salonsip plaster', 'type': 'DRUG', 'description': 'The plaster should be applied at the site of injury, which must be clean and dry and changed every 8 hours for a period of 48 hours of treatment (2 days).', 'armGroupLabels': ['Salonsip']}, {'name': 'Sabia plaster', 'type': 'DRUG', 'description': 'The plaster should be applied at the site of injury, which must be clean and dry and changed every 8 hours for a period of 48 hours of treatment (2 days).', 'armGroupLabels': ['Sabiá']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hisamitsu Farmaceutica do Brasil Ltda', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Emília Wakebe', 'oldOrganization': 'Hisamitsu Farmacêutica do Brasil Ltda.'}}}}