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.
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