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Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children (CAPSAPED)

Primary Purpose

Neuropathic Pain, Chronic Pain

Status
Not yet recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Capsaicin 8% patch
Hydrocolloid dressing
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Neuropathic Pain, Pediatric, Capsaicin, Randomized clinical trial

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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). 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 Criteria: 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.

Sites / Locations

  • CHU d'Amiens
  • CHU d'Angers
  • CHU de Bordeaux
  • CHU de Brest
  • CHU de Nantes
  • CHU de Lyon
  • CHU de Marseille
  • CHU de Montpellier
  • CHU de Toulouse
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

QUTENZA

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse event monitoring
Adverse event monitoring are collected during patch application and by phone calls in the following days.
Vital signs
Cardiac frequency in Bpm
Vital signs
Arterial pressure in mmHg
Dermal assessment
Dermal assessment is evaluated with question concerning the treated area (YES/NO)
Dermal assessment
Dermal assessment is evaluated with questions concerning the feel of the treated area (YES/NO)
Treatment related pain and use of analgesic medication
Intake of analgesic medication (YES/NO)
Duration of patch application
Duration of patch application in minutes
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
Functional disability evaluation (FDI)
Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome

Full Information

First Posted
July 25, 2023
Last Updated
August 17, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT05997979
Brief Title
Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children
Acronym
CAPSAPED
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2026 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 : 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).
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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Chronic Pain
Keywords
Neuropathic Pain, Pediatric, Capsaicin, Randomized clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multicentric randomized controlled superiority trial in parallel arms: experimental arm : Capsaicin 8% cutaneous patch control arm : Hydrocolloid dressing
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QUTENZA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Capsaicin 8% patch
Other Intervention Name(s)
QUTENZA®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hydrocolloid dressing
Other Intervention Name(s)
COMFEEL PLUS TRANSPARENT
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in Neuropathic Pain Symptom Inventory score (NPSI)
Description
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.
Time Frame
At baseline (day of the patch application) and 4 months after patch application
Secondary Outcome Measure Information:
Title
Adverse event monitoring
Description
Adverse event monitoring are collected during patch application and by phone calls in the following days.
Time Frame
At day 0, day 1, day 2, day 3 after patch application
Title
Vital signs
Description
Cardiac frequency in Bpm
Time Frame
At baseline, Month 1, Month 2, Month 3 and Month 4
Title
Vital signs
Description
Arterial pressure in mmHg
Time Frame
At baseline, Month 1, Month 2, Month 3 and Month 4
Title
Dermal assessment
Description
Dermal assessment is evaluated with question concerning the treated area (YES/NO)
Time Frame
At baseline
Title
Dermal assessment
Description
Dermal assessment is evaluated with questions concerning the feel of the treated area (YES/NO)
Time Frame
Month 1, Month 2, Month 3 and Month 4
Title
Treatment related pain and use of analgesic medication
Description
Intake of analgesic medication (YES/NO)
Time Frame
At baseline, day 1, day 2, Month 1, Month 2, Month 3 and Month 4
Title
Duration of patch application
Description
Duration of patch application in minutes
Time Frame
During patch application : at baseline and at Month 3 if it is applicable
Title
Neuropathic Pain Symptom Inventory score (NPSI)
Description
Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome
Time Frame
At baseline, Month 1, Month 2, Month 3 and Month 4
Title
Functional disability evaluation (FDI)
Description
Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome
Time Frame
At baseline, Month 1, Month 2, Month 3 and Month 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe J LE MOINE, MD
Phone
+33298223956
Email
philippe.lemoine@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe J LE MOINE, MD
Organizational Affiliation
CHU of Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Amiens
City
Amiens
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine DEVOLDERE
Facility Name
CHU d'Angers
City
Angers
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petronela RACHIERU
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie BERCIAUD
Facility Name
CHU de Brest
City
Brest
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe LE MOINE
Facility Name
CHU de Nantes
City
Brest
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marine LETELLIER
Facility Name
CHU de Lyon
City
Lyon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine SIMONIN
Facility Name
CHU de Marseille
City
Marseille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile MAREAU
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric BERNARD
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnès SUC
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Anne SEVEQUE

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
IPD Sharing Access Criteria
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.

Learn more about this trial

Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children

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