Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children

Recruiting Phase 3 Interventional Study
Neuropathic Pain Chronic Pain
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
46 (estimated)
Sponsor
University Hospital, Brest · Other
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About This Trial
This study concerns children aged to 12 to 17-years with local chronic neuropathic pain after trauma or surgery. It is a multicentric randomized controlled superiority trial in parallel arms : * experimental arm: Capsaicin 8% cutaneous patch * controlled arm : Hydrocolloid dressing Treatment with capsaicin application is realized at baseline, and repeated 3 months after the first patch applicat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Children aged 12 to 17 years (lower age limit of 12 has been chosen to ensure NPSI full filling). * Male or female. * Persistent neuropathic pain more than 3 months after surgery or trauma despite treatment following recommendations. * Neuropathic pain is defined as a DN4 scor…
Contacts

Philippe LE MOINE, MD

+33298223956

philippe.lemoine@chu-brest.fr

CONTACT