Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children

Официальное название

Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch for the Treatment of Chronic Postsurgical or Post-traumatic Neuropathic Pain: a Randomized Placebo Controlled Study in Children Aged 12 to 17-y

Обзор

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 application if needed. Tolerance is assessed during each application and by phone call in following days until stop of cold need. Efficacy is assessed monthly by clinical consultation until the end of the study (month 4).

Подробное описание

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 surgery are proposed to participate the trial.

Children with persistant neuropathic pain (DN4 (Diagnostic Neuropathic Pain) \> or = 3/7 ou DN4 \>or = 4/10) despite oral treatment following recommendations for neuropathic pain may be enrolled in the study.

For children not very painful (NRS-11 (Numeric Rating Scale) \< 7 and FDI (Functional Disability Inventory) \< 30) and without any oral treatment for neuropathic pain, the study may be proposed as first line treatment.

If both the child and his/her parents accept the trial, he/she will be included in the study.

It is a multicentric randomized controlled superiority trial in parallel arms :

* experimental arm: Capsaicin 8% cutaneous patch * controlled arm : Hydrocolloid dressing

At M0, take place : baseline evaluation, agreement consent signature, inclusion and randomization, as well as first treatment application either capsaicin cutaneous patch or hydrocolloid dressing.

, If needed, the treatment may be done twice with a second application three months later (M3).

Tolerance is assessed during each application and by phone call in following days until stop of cold need.

Efficacy is assessed monthly by clinical consultation until the end of the study 4 months later (M4).

Вмешательства

• Препарат Capsaicin 8% patch
  Patients will receive Capsaicin 8% patch at the inclusion of the study and three months later if it is necessary (persistant pain). Qutenza should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.
• Устройство Hydrocolloid dressing
  Patients will receive Hydrocolloid dressing at the inclusion of the study and three months later if it is necessary (persistant pain). Hydrocolloid dressing should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.

Первичные конечные точки

• The change in Neuropathic Pain Symptom Inventory score (NPSI) [Срок оценки: At baseline (day of the patch application) and 4 months after patch application]

Вторичные конечные точки (9)

• Adverse event monitoring [Срок оценки: At day 0, day 1, day 2, day 3 after patch application]
• Vital signs [Срок оценки: At baseline, Month 1, Month 2, Month 3 and Month 4]
• Vital signs [Срок оценки: At baseline, Month 1, Month 2, Month 3 and Month 4]
• Dermal assessment [Срок оценки: At baseline]
• Dermal assessment [Срок оценки: Month 1, Month 2, Month 3 and Month 4]
• Treatment related pain and use of analgesic medication [Срок оценки: At baseline, day 1, day 2, Month 1, Month 2, Month 3 and Month 4]
• Duration of patch application [Срок оценки: During patch application : at baseline and at Month 3 if it is applicable]
• Neuropathic Pain Symptom Inventory score (NPSI) [Срок оценки: At baseline, Month 1, Month 2, Month 3 and Month 4]
• Functional disability evaluation (FDI) [Срок оценки: At baseline, Month 1, Month 2, Month 3 and Month 4]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 10 центров

• CHU d'Amiens — Amiens
• CHU d'Angers — Angers
• CHU de Bordeaux — Bordeaux
• CHU de Brest — Brest
• CHU de Nantes — Brest
• CHU de Lyon — Lyon
• CHU de Marseille — Marseille
• CHU de Montpellier — Montpellier
• … и ещё 2 центра

Идентификаторы

NCT: NCT05997979 · 29BRC21.0184

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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