NCT05299294 Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years Old
| NCT ID | NCT05299294 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Brest |
| Condition | Neuropathic Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-05-12 |
| Primary Completion | 2027-05-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2022-05-12 with a primary completion date of 2027-05-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 . Medical data will be recorded and at home, the child or his family will collect pain assessment data. Tolerance 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 (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.)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.
Eligibility Criteria
Inclusion Criteria: * chronic localized neuropathic pain * capsaicin 8% patch treatment indication validated in a pediatric chronic pain center * agreement for participation by child and parents Exclusion Criteria: * already treated with capsaicin 8% patch in the same body area * already treated in the same study in an other investigation center * non willing to participate or parents not willing participation to the study
Contact & Investigator
Philippe J Le Moine, MD
PRINCIPAL INVESTIGATOR
CHRU of Brest
Frequently Asked Questions
Who can join the NCT05299294 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Neuropathic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05299294 currently recruiting?
Yes, NCT05299294 is actively recruiting participants. Contact the research team at philippe.lemoine@chu-brest.fr for enrollment information.
Where is the NCT05299294 trial being conducted?
This trial is being conducted at Angers, France, Bordeaux, France, Bourg-en-Bresse, France, Brest, France and 11 additional locations.
Who is sponsoring the NCT05299294 clinical trial?
NCT05299294 is sponsored by University Hospital, Brest. The principal investigator is Philippe J Le Moine, MD at CHRU of Brest. The trial plans to enroll 160 participants.