Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT04647435
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2020-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 396}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-11-23', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'At least 50% of maximum pain relief score (TOTPARmax)', 'timeFrame': 'Change from Baseline to 6 hours'}], 'secondaryOutcomes': [{'measure': 'Adverse events incidence and classification', 'timeFrame': 'During treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postsurgical Pain', 'Third Molar Extraction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of APSCTC compared to two active drugs in acute pain relief.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Males and Females aged 18 to 40 years;\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;\n* Participants who require extraction of impacted mandibular third molar.\n\nMain Exclusion Criteria:\n\n* Known hypersensitivity to the formula components used during the clinical trial;\n* Previous history of alcohol or drugs abuse diagnosed by DSM-V;\n* Previous history of renal failure from moderate to severe;\n* Women who are pregnant, lactating, or positive for β - hCG urine test.'}, 'identificationModule': {'nctId': 'NCT04647435', 'acronym': 'CARLOTA', 'briefTitle': 'Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apsen Farmaceutica S.A.'}, 'officialTitle': 'National, Multicentre, Randomized, Double-blind, Triple-dummy Active-Controled Phase III Clinical Trial to Evaluate the Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction.', 'orgStudyIdInfo': {'id': 'APS001/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APSCTC', 'description': 'Oral tablets every 6h for 3 days', 'interventionNames': ['Drug: APSCTC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Toragesic®', 'description': 'Oral tablets every 6h for 3 days', 'interventionNames': ['Drug: Toragesic®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tramal®', 'description': 'Oral tablets every 6h for 3 days', 'interventionNames': ['Drug: Tramal®']}], 'interventions': [{'name': 'APSCTC', 'type': 'DRUG', 'description': 'APSCTC + Toragesic® placebo + Tramal® placebo', 'armGroupLabels': ['APSCTC']}, {'name': 'Toragesic®', 'type': 'DRUG', 'description': 'APSCTC placebo + Toragesic® + Tramal® placebo', 'armGroupLabels': ['Toragesic®']}, {'name': 'Tramal®', 'type': 'DRUG', 'description': 'APSCTC placebo + Toragesic® placebo + Tramal®', 'armGroupLabels': ['Tramal®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Valinhos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.', 'geoPoint': {'lat': -22.97056, 'lon': -46.99583}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apsen Farmaceutica S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}