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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 :
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).
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 :
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QUTENZA | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin 8% patch | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The change in Neuropathic Pain Symptom Inventory score (NPSI) | 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. | At baseline (day of the patch application) and 4 months after patch application |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event monitoring | Adverse event monitoring are collected during patch application and by phone calls in the following days. | At day 0, day 1, day 2, day 3 after patch application |
| Vital signs |
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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 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).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe LE MOINE, MD | Contact | +33298223956 | philippe.lemoine@chu-brest.fr |
| Name | Affiliation | Role |
|---|---|---|
| Philippe J LE MOINE, MD | CHU of Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Amiens | Recruiting | Amiens | France |
All collected data that underlie results in a publication
Data will be available beginning three years and ending fifteen years following the final study report completion
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| D057968 | Transdermal Patch |
| D047070 | Bandages, Hydrocolloid |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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Multicentric randomized controlled superiority trial in parallel arms:
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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.
|
|
| Hydrocolloid dressing | Device | 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. |
|
|
Cardiac frequency in Bpm
| At baseline, Month 1, Month 2, Month 3 and Month 4 |
| Vital signs | Arterial pressure in mmHg | At baseline, Month 1, Month 2, Month 3 and Month 4 |
| Dermal assessment | Dermal assessment is evaluated with question concerning the treated area (YES/NO) | At baseline |
| Dermal assessment | Dermal assessment is evaluated with questions concerning the feel of the treated area (YES/NO) | Month 1, Month 2, Month 3 and Month 4 |
| Treatment related pain and use of analgesic medication | Intake of analgesic medication (YES/NO) | At baseline, day 1, day 2, Month 1, Month 2, Month 3 and Month 4 |
| Duration of patch application | Duration of patch application in minutes | During patch application : at baseline and at Month 3 if it is applicable |
| Neuropathic Pain Symptom Inventory score (NPSI) | Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome | At baseline, Month 1, Month 2, Month 3 and Month 4 |
| Functional disability evaluation (FDI) | Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome | At baseline, Month 1, Month 2, Month 3 and Month 4 |
| CHU d'Angers | Recruiting | Angers | France |
|
| CHU de Bordeaux | Recruiting | Bordeaux | France |
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| CHU de Brest | Recruiting | Brest | France |
|
| CHU de Nantes | Recruiting | Brest | France |
|
| CHU de Lyon | Recruiting | Lyon | France |
|
| CHU de Marseille | Recruiting | Marseille | France |
|
| CHU de Montpellier | Recruiting | Montpellier | France |
|
| CHU de Tours | Recruiting | Tours | France |
|
| Institut Gustave Roussy | Recruiting | Villejuif | France |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004864 | Equipment and Supplies |
| D001458 | Bandages |