Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2025-12-30 @ 12:31 PM
Study NCT ID:
NCT01562704
Status:
COMPLETED
Last Update Posted:
2013-01-14
First Post:
2012-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-11', 'studyFirstSubmitDate': '2012-01-27', 'studyFirstSubmitQcDate': '2012-03-22', 'lastUpdatePostDateStruct': {'date': '2013-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 100 min after administration of paracetamol or placebo in brain structures', 'timeFrame': '100 min after administration of paracetamol or placebo'}], 'secondaryOutcomes': [{'measure': 'Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 180 min after administration of paracetamol or placebo in brain structures', 'timeFrame': '180 min after administration of paracetamol or placebo'}]}, 'conditionsModule': {'keywords': ['mechanism of action of paracetamol in the brain structures'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '26229445', 'type': 'DERIVED', 'citation': 'Pickering G, Kastler A, Macian N, Pereira B, Valabregue R, Lehericy S, Boyer L, Dubray C, Jean B. The brain signature of paracetamol in healthy volunteers: a double-blind randomized trial. Drug Des Devel Ther. 2015 Jul 23;9:3853-62. doi: 10.2147/DDDT.S81004. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'Paracetamol is one of the most widely used analgesic in the world, indicated for the symptomatic treatment of fever and pain. The objective of this study is to evaluate the mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools (functional MRI and test inducing pain by thermal stimulation.', 'detailedDescription': 'Visit 1 / Visit 2 Inclusion of the subject, Clinical examination Trainings tests\n\nStudy period 1 Clinical examination Measurement of the basal pain thresholds Administration of product (T0) T0+100min : Thermal stimulation according to the established paradigm and fMRI data acquisition T0+180min : Thermal stimulation according to the established paradigm and fMRI data acquisition\n\nStudy period 2: same of period 1.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Healthy volunteers\n* Aged at last 18 years and over 60 years\n* Male\n* Non-smoking subject\n* Fasting coffe, tea, coca-cola or other stimulant products since the last evening\n* Subject free of any treatment within 7 days prior to inclusion including no use of analgesics or anti-inflammatory treatments\n\nExclusion Criteria:\n\n* Contraindications to the administration of paracetamol\n* Contraindications to the completion of MRI\n* Medical history and/or surgical judged by the investigator as being incompatible with the test\n* Progressive disease at the inclusion'}, 'identificationModule': {'nctId': 'NCT01562704', 'acronym': 'IRMf', 'briefTitle': 'Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI', 'orgStudyIdInfo': {'id': 'CHU-0110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'paracetamol', 'interventionNames': ['Drug: Paracetamol (drug)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo'}], 'interventions': [{'name': 'Paracetamol (drug)', 'type': 'DRUG', 'description': 'The objective of this study is to evaluate the mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools (functional MRI and test inducing pain by thermal stimulation', 'armGroupLabels': ['paracetamol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Gisèle PICKERING', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr. Gisèle PICKERING (MCU, PH)', 'class': 'UNKNOWN'}, {'name': 'Dr. Betty JEAN (PH)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}