Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-25 @ 6:36 PM
Study NCT ID:
NCT05299294
Status:
RECRUITING
Last Update Posted:
2024-09-24
First Post:
2021-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years Old
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2027-09-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-22', 'studyFirstSubmitDate': '2021-12-23', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success or failure of pain treatment : Number of patients with success and number of patients with failure of treatment with capsaicin', 'timeFrame': '3 months after last patch application', 'description': 'The success is defined by the absence of use of pain medication during the three months after the end of capsaicin application protocol'}], 'secondaryOutcomes': [{'measure': 'Indication of capsaicin use', 'timeFrame': 'At recruitment visit', 'description': 'Indication for treatment with capsaicine will be collected (context of emergence of pain, descriptive data)'}, {'measure': 'Success or failure of pain treatment : Number of patients who use or not use antalgic and/or comfort medication (including for improving sleep)', 'timeFrame': 'Baseline and 1 month, 3 months and 6 months after patch application.', 'description': 'Use of antalgic and/or comfort medication (including for improving sleep). Success is de fined by the non use of antalgic and/or comfort medication (including for improving sleep)'}, {'measure': 'Neuropathic pain evaluation for child aged from 0 to 4 years', 'timeFrame': 'Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.', 'description': 'Score of HECP (Hetero-Evaluation of Child Pain) questionnaire, score from 0 to 10 (a higher score means a worse outcome)'}, {'measure': 'Neuropathic pain evaluation for child with intellectual deficiency', 'timeFrame': 'Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.', 'description': 'Score of PAGID (Pain Assessment Grid - Intellectual Deficiency) or PPP (Pediatric Pain Profile) questionnaire, higher scores are worse outcome'}, {'measure': 'Neuropathic pain description for child aged from 5 to 11 years', 'timeFrame': 'Baseline and 1 month, 3 months and 6 months after patch application.', 'description': 'Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory), questionnaire with support, score from 0 to 100, higher score is worse outcome'}, {'measure': 'Neuropathic pain diagnostic for child aged from 5 to 11 years', 'timeFrame': 'Baseline and 1 month, 3 months and 6 months after patch application.', 'description': 'Global score of pPN4 (Paediatric Neuropathic Pain 4 points) questionnaire, score from 0 to 10, higher score is worse item'}, {'measure': 'Neuropathic pain evaluation for child aged from 5 to 11 years', 'timeFrame': 'Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.', 'description': 'Score of pVAS (Paediatric Visual Analogic Scale) or NS (Numeric Scale) or Revised Faces Pain Scales, score from 0 to 10, higher score is worse outcome'}, {'measure': 'Neuropathic pain description for child aged from 12 to 17 years', 'timeFrame': 'Baseline and 1 month, 3 months and 6 months after patch application.', 'description': 'Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome'}, {'measure': 'Neuropathic pain evaluation for child aged from 12 to 17 years', 'timeFrame': 'Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.', 'description': 'Score of VAS (Visual Analogic Scale) or NS (Numeric Scale), score from 0 to 10, higher score is worse outcome'}, {'measure': 'Neuropathic pain diagnostic for child aged from 12 to 17 years', 'timeFrame': 'Baseline and 1 month, 3 months and 6 months after patch application.', 'description': 'Global score of NP4 questionnaire (Neuropathic Pain 4 points), score from 0 to 10, higher score is worse item'}, {'measure': 'Functional disability evaluation for child aged from 5 to 17 years', 'timeFrame': 'Baseline and 1 month, 3 months and 6 months after patch application.', 'description': 'Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome'}, {'measure': 'Pain description for child aged from 5 to 17 years : number of painful access', 'timeFrame': 'Baseline and 1 month, 3 months and 6 months after patch application.', 'description': 'Number of painful access (crisis) in one day'}, {'measure': 'Pain description for child aged from 5 to 17 years : duration of painful access', 'timeFrame': 'Baseline and 1 month, 3 months and 6 months after patch application.', 'description': 'Mean duration of painful access (crisis) in minutes'}, {'measure': 'Pain description for child aged from 5 to 17 years : trigger factor of the painful access', 'timeFrame': 'Baseline and 1 month, 3 months and 6 months after patch application.', 'description': 'Type of trigger factor that leads to the painful access'}, {'measure': 'Pain description for child aged from 5 to 17 years : sensation', 'timeFrame': 'Baseline and 1 month, 3 months and 6 months after patch application.', 'description': 'Description of sensation reported by the child (sensation spontaneously described, qualitative data)'}, {'measure': 'Pain description (observed signs) for child aged from 0 to 4 years or with intellectual deficiency', 'timeFrame': 'Baseline and 1 month, 3 months and 6 months after patch application.', 'description': 'Description of observed signs related to pain'}, {'measure': 'Pain description (sleep quality) for child aged from 0 to 4 years or with intellectual deficiency', 'timeFrame': 'Baseline and 1 month, 3 months and 6 months after patch application.', 'description': 'Description of sleep quality (night awakening / week)'}, {'measure': 'Pain description (child behaviour) for child aged from 0 to 4 years or with intellectual deficiency', 'timeFrame': 'Baseline and 1 month, 3 months and 6 months after patch application.', 'description': 'Description of child behaviour related to pain (antalgic position)'}, {'measure': 'Tolerance assessment (duration of patch application)', 'timeFrame': 'Baseline, 3 months and 6 months', 'description': 'Duration of patch application in minutes'}, {'measure': 'Tolerance assessment (number of patch used)', 'timeFrame': 'Baseline, 3 months and 6 months', 'description': 'Number of patch used during the application'}, {'measure': 'Tolerance assessment (cutaneous state)', 'timeFrame': 'Baseline, 3 months and 6 months', 'description': 'Cutaneous state (burning, erythema, healthy skin, other) just after patch removal'}, {'measure': 'Tolerance assessment (skin aspect)', 'timeFrame': 'Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application', 'description': 'Local aspect of skin : presence of erythema Yes or No, in the hours and days following patch application'}, {'measure': 'Tolerance assessment (icing)', 'timeFrame': 'Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application', 'description': 'Need for icing (YES/NO) against pain'}, {'measure': 'Tolerance assessment (rescue medication)', 'timeFrame': 'Baseline, 3 months and 6 months : 4, 8, 24, 48 and 72 hours after patch application', 'description': 'Intake of rescue medication against pain (YES/NO)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuropathic Pain', 'Pediatric', 'Capsaicin'], 'conditions': ['Neuropathic Pain', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'Patients aged less than 18-y with validated 8% capsaicin patch treatment in routine healthcare will be offered to participate the study. If they accept it as well as their parents, they will be included in the study .\n\nMedical data will be recorded and at home, the child or his family will collect pain assessment data.\n\nTolerance will be monitored at home by phone call from investigational team every 24 hours until normalization. (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.) Children will be assessed via scales at inclusion and 1-month, 3-month and 6-month.', 'detailedDescription': 'Children and teenagers aged less than 18-y, with chronic localized neuropathic pain, may be treated by capsaicin 8% patch. If this indication is validated in pediatric chronic pain consultation, they will be offered to participate the study. If they accept it as well as their parents, they will be included in the study.\n\nTreatment application will follow recommendations and be realized in out patient clinic with trained nurses.\n\nTolerance will be assessed by phone call every 24 Hours by investigational team until normalization. Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.\n\nEfficacy will be monitored with usual pain and neuropathic pain tools, adapted to age and cognitive capacities, one month after application.\n\nTreatment may be done three times if needed with a three month interval between each capsaicin patch application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged less than 18-y with chronic localized neuropathic pain and capsaicin 8% patch indication validated in a pediatric chronic pain center.\n\npatient with intellectual development disabilities are accepted', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic localized neuropathic pain\n* capsaicin 8% patch treatment indication validated in a pediatric chronic pain center\n* agreement for participation by child and parents\n\nExclusion Criteria:\n\n* already treated with capsaicin 8% patch in the same body area\n* already treated in the same study in an other investigation center\n* non willing to participate or parents not willing participation to the study'}, 'identificationModule': {'nctId': 'NCT05299294', 'acronym': 'CAPSULE', 'briefTitle': 'Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years Old', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years', 'orgStudyIdInfo': {'id': '29BRC21.0184 (CAPSULE)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Collecting data on children receiving capsaicine 8% patch for localized neuropathic pain'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'state': 'France', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Petronela Rachieru Sourisseau, MD', 'role': 'CONTACT', 'email': 'perachieru@chu-angers.fr', 'phone': '+33241355741'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '33076', 'city': 'Bordeaux', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvie Berciaud, MD', 'role': 'CONTACT', 'email': 'sylvie.berciaud@chu-bordeaux.fr', 'phone': '+33557820194'}], 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '01000', 'city': 'Bourg-en-Bresse', 'state': 'France', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clémence Dal-Col, MD', 'role': 'CONTACT', 'email': 'cdalcol@ch-bourg01.fr', 'phone': '+33474454357'}], 'facility': 'CHR Bourg en Bresse', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'zip': '29609', 'city': 'Brest', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe J LE MOINE, MD', 'role': 'CONTACT', 'email': 'philippe.lemoine@chu-brest.fr', 'phone': '+33298223956'}], 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14000', 'city': 'Caen', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandra Desdoits, MD', 'role': 'CONTACT', 'email': 'desdoits-a@chu-caen.fr', 'phone': '+33231064486'}], 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '38043', 'city': 'Grenoble', 'state': 'France', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mariel Cartal, MD', 'role': 'CONTACT', 'email': 'mcartal@chu-grenoble.fr', 'phone': '+33476767987'}], 'facility': 'CHU Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59037', 'city': 'Lille', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Justine Avez-Couturier, MD', 'role': 'CONTACT', 'email': 'justine.couturier@chru-lille.fr', 'phone': '+33320444671'}], 'facility': 'CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'state': 'France', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe Piguet, MD', 'role': 'CONTACT', 'email': 'christophe.piguet@chu-limoges.fr', 'phone': '+33555056801'}], 'facility': 'CHU Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13005', 'city': 'Marseille', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cécile Mareau, MD', 'role': 'CONTACT', 'email': 'cecile.mareau@ap-hm.fr', 'phone': '+33491386302'}], 'facility': 'CHU Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34090', 'city': 'Montpellier', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéri Bernard, MD', 'role': 'CONTACT', 'email': 'f-bernard@chu-montpellier.fr'}], 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54511', 'city': 'Nancy', 'state': 'France', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ludovic Mansuy, PHD', 'role': 'CONTACT', 'email': 'lu.mansuy@chru-nancy.fr', 'phone': '+33383154734'}], 'facility': 'CHU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44093', 'city': 'Nantes', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marine Letellier', 'role': 'CONTACT', 'email': 'marine.letellier@chu-nantes.fr', 'phone': '+33240083610'}], 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75019', 'city': 'Paris', 'state': 'France', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Esther Soyeux, MS', 'role': 'CONTACT', 'email': 'esther.soyeux@aphp.fr', 'phone': '+33140034102'}], 'facility': 'CHU Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75571', 'city': 'Paris', 'state': 'France', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Barbara Tourniaire, MD', 'role': 'CONTACT', 'email': 'barbara.tourniaire@aphp.fr', 'phone': '+33144737392'}], 'facility': 'CHU Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76031', 'city': 'Rouen', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alice Petit-Ledo, MD', 'role': 'CONTACT', 'email': 'alice.petit-ledo@chu-rouen.fr', 'phone': '+33232885898'}], 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '67098', 'city': 'Strasbourg', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu REBERT, MD', 'role': 'CONTACT', 'email': 'Mathieu.rebert@chru-strasbourg.fr'}], 'facility': 'CHRU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Agnès Suc, MD', 'role': 'CONTACT', 'email': 'suc.a@chu-toulouse.fr', 'phone': '+33534558661'}], 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94805', 'city': 'Villejuif', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Anne Sevèque Sevèque, MD', 'role': 'CONTACT', 'email': 'marie-anne.seveque@gustaveroussy.fr', 'phone': '+33142114433'}], 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '80054', 'city': 'Amiens', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sandrine SORIOT-THOMAS', 'role': 'CONTACT', 'email': 'soriot-thomas.sandrine@chu-amiens.fr', 'phone': '+33322087997'}], 'facility': "CHU d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sabine Simonin, MD', 'role': 'CONTACT', 'email': 'sabine.simonin@chu-lyon.fr', 'phone': '+33472118866'}], 'facility': 'CHU Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Philippe J Le Moine, MD', 'role': 'CONTACT', 'email': 'philippe.lemoine@chu-brest.fr', 'phone': '+33298223956'}], 'overallOfficials': [{'name': 'Philippe J Le Moine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU of Brest'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation de France', 'class': 'OTHER'}, {'name': 'Fondation Apicil', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}