Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT01359020
Status:
COMPLETED
Last Update Posted:
2011-05-24
First Post:
2011-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D004177', 'term': 'Dipyrone'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000632', 'term': 'Aminopyrine'}, {'id': 'D047069', 'term': 'Pyrazolones'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 396}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-23', 'studyFirstSubmitDate': '2011-05-20', 'studyFirstSubmitQcDate': '2011-05-23', 'lastUpdatePostDateStruct': {'date': '2011-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antipyretic efficacy', 'timeFrame': 'Temperature was verified 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug.', 'description': 'The antipyretic efficacy was assessed comparing the time to the beggining of the action of the drugs, the difference between the final and inicial temperature and time of action.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Adverse Events were verified at 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug.', 'description': 'All adverse events were recorded.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fever', 'Ibuprofen', 'Acetaminophen', 'Dipyrone'], 'conditions': ['Fever']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the efficacy and tolerability of acetaminophen, dipyrone and ibuprofen to fever control in children.\n\nFor the efficacy asses were compared:\n\n* the time to start the action;\n* the action duration;\n* the difference between the basal temperature and the lower temperature in the study period.\n\nFor the tolerability asses all adverse events were recorded, as well as your intensity and the relation to the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male and female children aged 06 months to 06 years old, weight above 5 kilo and axillary temperature above 37,5 celsius degree.\n\nExclusion Criteria:\n\n* patients with a bad general heath state\n* patients with neoplasia, pepic ulcer, gastrointestinal bleeding,history of fever convulsion;\n* intolerant to dypirone, ibuprofen, acetaminophen or any other nonsteroidal antiinflammatory drug;\n* moderated or severe dehydration;\n* conscience state alteration;\n* not capable of ingest oral drugs;\n* patients being treated with steroids;\n* patients treated with antiinflammatory, analgesic and antipyretic drugs in the last 06 hours before the study.'}, 'identificationModule': {'nctId': 'NCT01359020', 'briefTitle': 'Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mantecorp Industria Quimica e Farmaceutica Ltd.'}, 'officialTitle': 'Randomized, Open Label, Comparative, Parallel, Multicenter Trial to Determinate the Efficacy Anf Tolerability of Ibuprofen, Acetaminophen and Dipyrone Drops to Fever Control in Children', 'orgStudyIdInfo': {'id': 'ALI/P/04-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ibuprofen', 'description': '10 milligram per kilo, oral administration', 'interventionNames': ['Drug: ibuprofen, dipyrone, acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acetaminophen', 'description': '10 milligram per kilo, oral administration', 'interventionNames': ['Drug: ibuprofen, dipyrone, acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dipyrone', 'description': '10 milligram per kilo, oral administration', 'interventionNames': ['Drug: ibuprofen, dipyrone, acetaminophen']}], 'interventions': [{'name': 'ibuprofen, dipyrone, acetaminophen', 'type': 'DRUG', 'description': 'The dosage for the three drugs was the same: 10 milligrams per kilo, oral administration', 'armGroupLabels': ['Acetaminophen', 'Dipyrone', 'Ibuprofen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50070-550', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Instituto de Medicina Integral Professor Fernando Figueira', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}], 'overallOfficials': [{'name': 'Claudia Patrícia DN Moura', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mantecorp Indústria Química e Farmacêutica Ltda.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mantecorp Industria Quimica e Farmaceutica Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Claudia Domingues', 'oldOrganization': 'Mantecorp'}}}}