Status:
RECRUITING
Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children
Lead Sponsor:
University Hospital, Brest
Conditions:
Neuropathic Pain
Chronic Pain
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
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 : * exp...
Detailed Description
Children aged to 12 to 17-years monitored in pediatric pain outpatient clinics in the designed investigation centers for a local chronic neuropathic pain lasting more than 2 months after trauma or sur...
Eligibility Criteria
Inclusion
- 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 score equal to or greater than 3/7 or 4/10, and localized in a nerve territory explained by the surgery or the trauma.
- Treatment, survey and follow up must be realized in an identified investigating center of the study
- For patients of childbearing potential: use of an adequate method of contraception\* during the course of the study through 48 hours after the last patch application (girls of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the first patch application).
- Adequate contraception includes sexual abstinence, progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide, combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods)
Exclusion
- Intellectual deficiency not allowing full filling of NPSI.
- Insufficient command of the French language to full fill NPSI and other evaluation tools.
- Parents' refusal of consent.
- Minor patients' opposition.
- Underlying neurological disease.
- Ongoing neurotoxic treatment.
- Already treated by capsaicin.
- Cutaneous lesion on pain area.
- Patient presenting a pain area on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of Qutenza SmPC.
Key Trial Info
Start Date :
March 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 5 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT05997979
Start Date
March 5 2024
End Date
April 5 2026
Last Update
December 17 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU d'Amiens
Amiens, France
2
CHU d'Angers
Angers, France
3
CHU de Bordeaux
Bordeaux, France
4
CHU de Brest
Brest, France