Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-01-02 @ 10:12 AM
Study NCT ID:
NCT07133360
Status:
COMPLETED
Last Update Posted:
2025-08-21
First Post:
2025-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Mixed Drugs vs Ibuprofen: a Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019066', 'term': 'Facies'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D014313', 'term': 'Trismus'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013035', 'term': 'Spasm'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative pain', 'timeFrame': '10 DAYS', 'description': 'VAS pain scale'}, {'measure': 'Swelling', 'timeFrame': '7 DAYS', 'description': 'Face measurement for swelling'}, {'measure': 'Trismus', 'timeFrame': '7 DAYS', 'description': 'Opening limitation'}], 'secondaryOutcomes': [{'measure': 'Rescue analgesia', 'timeFrame': '7 DAYS', 'description': 'Need for more medications'}, {'measure': 'Inflammatory profile', 'timeFrame': '7 days', 'description': 'Blood cytokines'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin B', 'Vitamin D', 'Melatonine', 'Ibuprofen', 'Third Molar'], 'conditions': ['Swelling Lips &Amp; Face', 'Pain', 'Trismus']}, 'descriptionModule': {'briefSummary': 'Combination of vitamins and melatonine compared with the conventional use of ibuprofen after surgical third molar extraction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers, non ibuprofen allergic, presence of impacted lower third molar\n\nExclusion Criteria:\n\n* Diseases that avoid surgical intervention'}, 'identificationModule': {'nctId': 'NCT07133360', 'acronym': 'CoctailRCT', 'briefTitle': 'Combination of Mixed Drugs vs Ibuprofen: a Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Cocktail of Vitamin B, Vitamin D and Melatonine VS Ibuprofen in the Surgical Third Molar Extraction. Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2019-000736-27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen 400', 'description': 'Three ibuprofen 400 doses', 'interventionNames': ['Procedure: Third molar extraction']}, {'type': 'EXPERIMENTAL', 'label': 'Coctail mixed Drugs', 'description': 'Vitamin D, Vitamin B and Melatonine at night instead Ibuprofen', 'interventionNames': ['Procedure: Third molar extraction']}], 'interventions': [{'name': 'Third molar extraction', 'type': 'PROCEDURE', 'description': 'Surgical third molar extraction with conventional medication', 'armGroupLabels': ['Coctail mixed Drugs', 'Ibuprofen 400']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'country': 'Spain', 'facility': 'Complutense University of Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Jesús Torres García Denche', 'investigatorAffiliation': 'Universidad Complutense de Madrid'}}}}