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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 10
- 主要终点
- The change in Neuropathic Pain Symptom Inventory score (NPSI)
研究概览
简要总结
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).
详细描述
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 :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
There is no mock cutaneous patch available for capsaicin 8% cutaneous patch. So we have chosen hydrocolloid dressing for placebo since it has no known effect on neuropathic pain and the tolerability is expected as excellent.
The patient should not be aware of the specific aspect of capsaicin 8% patch and the protocol of application will be exactly the same. This should keep the patient blinded for the study treatment.
The nurse who applies the patch is unblinded.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
QUTENZA
The experimental product is QUTENZA®, a cutaneous patch which contains 179 mg of capsaicin (capsaicin 8%).The patch measures 14 cm x 20 cm.
The second application takes place three months after the first application.
干预措施: Capsaicin 8% patch (Drug)
Placebo
The placebo comparator is a hydrocolloid dressing: COMFEEL PLUS TRANSPARENT, a medical device class IIb commercialized by Coloplast. The patch measures 15 cm x 15 cm.
The second application takes place three months after the first application.
干预措施: Hydrocolloid dressing (Device)
结局指标
主要结局
The change in Neuropathic Pain Symptom Inventory score (NPSI)
时间窗: At baseline (day of the patch application) and 4 months after patch application
The decrease in Neuropathic Pain Symptom Inventory score (NPSI) is evaluated before the first application (M0) of capsaicin or placebo and 4 months later (M4). NPSI (Neuropathic Pain Syndrome Inventory) is a questionnaire without support, score from 0 to 100, higher score is worse outcome.
次要结局
- Adverse event monitoring(At day 0, day 1, day 2, day 3 after patch application)
- Vital signs(At baseline, Month 1, Month 2, Month 3 and Month 4)
- Dermal assessment(Month 1, Month 2, Month 3 and Month 4)
- Treatment related pain and use of analgesic medication(At baseline, day 1, day 2, Month 1, Month 2, Month 3 and Month 4)
- Duration of patch application(During patch application : at baseline and at Month 3 if it is applicable)
- Neuropathic Pain Symptom Inventory score (NPSI)(At baseline, Month 1, Month 2, Month 3 and Month 4)
- Functional disability evaluation (FDI)(At baseline, Month 1, Month 2, Month 3 and Month 4)