Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-05 @ 10:17 PM
Study NCT ID:
NCT02869867
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2016-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yves-marie.pluchon@chd-vendee.fr', 'phone': '251446248', 'title': 'Dr Yves-Marie PLUCHON', 'phoneExt': '+33', 'organization': 'Centre Hospitalier Départemental Vendée'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Death, serious adverse events and other (non serious adverse events) were not assessed for the study', 'eventGroups': [{'id': 'EG000', 'title': 'Qutenza® without refrigerated cushion', 'description': 'Qutenza® without refrigerated cushion', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Qutenza® with refrigerated cushion', 'description': 'Qutenza® with refrigerated cushion\n\nrefrigerated cushion: refrigerated cushion', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analogue Pain Scale (Burning Pain)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Qutenza® without refrigerated cushion', 'description': 'Qutenza® without refrigerated cushion'}, {'id': 'OG001', 'title': 'Qutenza® with refrigerated cushion', 'description': 'Qutenza® with refrigerated cushion\n\nrefrigerated cushion: refrigerated cushion'}], 'classes': [{'categories': [{'measurements': [{'value': '6.99', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '7.77'}, {'value': '3.78', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '4.56'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.20', 'ciLowerLimit': '2.09', 'ciUpperLimit': '4.31', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'after 1 hour of installation of Qutenza patch', 'description': 'Burning pain will be estimated by the patient using a non-graduated 10 cm line, presented horizontally to the patient with the extreme position of the vertical border on the left (0mm) representing the absence of perceived pain and the extreme position on the right (10 cm), the perception of the maximum pain that the patient can imagine. The information obtained is measured and translated into a score between 0 and 10.\n\nThe patient will be asked: "How would you rate the intensity of pain caused by Qutenza patch application?', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat Population (all participants who received a Qutenza patch)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Qutenza® without refrigerated cushion', 'description': 'Qutenza® without refrigerated cushion'}, {'id': 'FG001', 'title': 'Qutenza® with refrigerated cushion', 'description': 'Qutenza® with refrigerated cushion\n\nrefrigerated cushion: refrigerated cushion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Qutenza® Without Refrigerated Cushion', 'description': 'Qutenza® without refrigerated cushion'}, {'id': 'BG001', 'title': 'Qutenza® With Refrigerated Cushion', 'description': 'Qutenza® with refrigerated cushion\n\nrefrigerated cushion: refrigerated cushion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51', 'spread': '12', 'groupId': 'BG000'}, {'value': '49', 'spread': '14', 'groupId': 'BG001'}, {'value': '50', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'All analyses were performed according to the intention-to-treat principle by including all randomized patients to whom the Qutenza® patch was applied.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-15', 'size': 1134021, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-07T04:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2016-08-12', 'resultsFirstSubmitDate': '2023-06-15', 'studyFirstSubmitQcDate': '2016-08-16', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-03-15', 'studyFirstPostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Pain Scale (Burning Pain)', 'timeFrame': 'after 1 hour of installation of Qutenza patch', 'description': 'Burning pain will be estimated by the patient using a non-graduated 10 cm line, presented horizontally to the patient with the extreme position of the vertical border on the left (0mm) representing the absence of perceived pain and the extreme position on the right (10 cm), the perception of the maximum pain that the patient can imagine. The information obtained is measured and translated into a score between 0 and 10.\n\nThe patient will be asked: "How would you rate the intensity of pain caused by Qutenza patch application?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Localized Neuropathic Pain']}, 'referencesModule': {'references': [{'pmid': '39532578', 'type': 'RESULT', 'citation': 'Tailliez N, Planche L, Dorion A, Kacki N, Dimet J, Pluchon YM. Effect of Cooling Capsaicin Application Site on Reducing Burning Sensation in Neuropathic Pain Patients: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Apr;26(2):e159-e164. doi: 10.1016/j.pmn.2024.09.001. Epub 2024 Nov 12.'}]}, 'descriptionModule': {'briefSummary': 'Nursing study, prospective, randomized, two-center open-label.\n\nPatients will be randomized into two groups during their first laying Qutenza®:\n\n* Patients receiving the laying of Qutenza® without refrigerated cushion\n* Patients receiving the laying of Qutenza® associated with a refrigerated cushion\n\nThe objective of the study is to evaluate the effectiveness of the application of cold to the reduction of pain (burning) after one hour of patch installation high concentration capsaicin (Qutenza®) in patients localized neuropathic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major\n* Do not opposing the participation in the study\n* Monitoring in the case of localized neuropathic pain\n* Diagnostic with neuropathic pain score ≥ 4\n* Neuropathic pain conventional treatment failure of first-line\n* Front advantage of laying a first patch Qutenza®\n* With ability to understand the proposed study\n\nExclusion Criteria:\n\n* Patch Installation on the feet, face, mucous membranes\n* Eutectic mixture of local anesthetics (EMLA) Pose premedication\n* Having Already received prior to the installation of a patch of Qutenza®\n* Allergy to components Qutenza®\n* Known and poorly stabilized hypertension\n* Known cryoglobulinaemia\n* Pregnant or lactating women\n* Patient enjoying a measure of legal protection (guardianship, guardianship ...)\n* Private Patient freedom\n* No affiliation to a social security scheme.\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT02869867', 'acronym': 'DIDOCAP', 'briefTitle': 'Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Departemental Vendee'}, 'officialTitle': 'Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP', 'orgStudyIdInfo': {'id': 'CHD049-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Qutenza® without refrigerated cushion', 'description': 'Qutenza® without refrigerated cushion'}, {'type': 'EXPERIMENTAL', 'label': 'Qutenza® with refrigerated cushion', 'description': 'Qutenza® with refrigerated cushion', 'interventionNames': ['Other: refrigerated cushion']}], 'interventions': [{'name': 'refrigerated cushion', 'type': 'OTHER', 'description': 'refrigerated cushion', 'armGroupLabels': ['Qutenza® with refrigerated cushion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85300', 'city': 'Challans', 'country': 'France', 'facility': 'CHLVO de Challans', 'geoPoint': {'lat': 46.8458, 'lon': -1.87942}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'CHD Vendée de la Roche sur Yon', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Clinique Brétéché', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Departemental Vendee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}