Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years Old

NCT05299294 | Recruiting

• 1 other identifier: 29BRC21.0184 (CAPSULE)
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 20

Brief Summary

Patients aged less than 18-y with validated 8% capsaicin patch treatment in routine healthcare will be offered to participate the study. If they accept it as well as their parents, they will be included in the study . Medical data will be recorded and at home, the child or his family will collect pain assessment data. Tolerance will be monitored at home by phone call from investigational team every 24 hours until normalization. (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.) Children will be assessed via scales at inclusion and 1-month, 3-month and 6-month.

Conditions

Neuropathic Pain; Chronic Pain

Keywords

Neuropathic Pain; Pediatric; Capsaicin

Outcome Measures

Primary Outcomes (1)

• Success or failure of pain treatment : Number of patients with success and number of patients with failure of treatment with capsaicin

  The success is defined by the absence of use of pain medication during the three months after the end of capsaicin application protocol

  3 months after last patch application

Secondary Outcomes (24)

• Indication of capsaicin use

  At recruitment visit

• Success or failure of pain treatment : Number of patients who use or not use antalgic and/or comfort medication (including for improving sleep)

  Baseline and 1 month, 3 months and 6 months after patch application.

• Neuropathic pain evaluation for child aged from 0 to 4 years

  Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.

• Neuropathic pain evaluation for child with intellectual deficiency

  Baseline, 3 months, 6 months and 1 month, 3 months and 6 months after patch application.

• Neuropathic pain description for child aged from 5 to 11 years

  Baseline and 1 month, 3 months and 6 months after patch application.

Interventions

Data collection OTHER

Collecting data on children receiving capsaicine 8% patch for localized neuropathic pain

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

patients aged less than 18-y with chronic localized neuropathic pain and capsaicin 8% patch indication validated in a pediatric chronic pain center. patient with intellectual development disabilities are accepted

You may qualify if:

• chronic localized neuropathic pain
• capsaicin 8% patch treatment indication validated in a pediatric chronic pain center
• agreement for participation by child and parents

You may not qualify if:

• already treated with capsaicin 8% patch in the same body area
• already treated in the same study in an other investigation center
• non willing to participate or parents not willing participation to the study

Sponsors & Collaborators

• University Hospital, Brest: lead
• Fondation de France: collaborator
• Fondation Apicil: collaborator

Study Sites (20)

CHU Angers

Angers, France, 49933, France

NOT YET RECRUITING

CHU Bordeaux

Bordeaux, France, 33076, France

RECRUITING

CHR Bourg en Bresse

Bourg-en-Bresse, France, 01000, France

NOT YET RECRUITING

CHU de Brest

Brest, France, 29609, France

RECRUITING

CHU Caen

Caen, France, 14000, France

RECRUITING

CHU Grenoble

Grenoble, France, 38043, France

NOT YET RECRUITING

CHU Lille

Lille, France, 59037, France

RECRUITING

CHU Limoges

Limoges, France, 87042, France

NOT YET RECRUITING

CHU Marseille

Marseille, France, 13005, France

RECRUITING

CHU Montpellier

Montpellier, France, 34090, France

RECRUITING

CHU Nancy

Nancy, France, 54511, France

NOT YET RECRUITING

CHU Nantes

Nantes, France, 44093, France

RECRUITING

CHU Robert Debré

Paris, France, 75019, France

NOT YET RECRUITING

CHU Trousseau

Paris, France, 75571, France

NOT YET RECRUITING

CHU Rouen

Rouen, France, 76031, France

RECRUITING

CHRU Strasbourg

Strasbourg, France, 67098, France

RECRUITING

CHU Toulouse

Toulouse, France, 31059, France

RECRUITING

Institut Gustave Roussy

Villejuif, France, 94805, France

RECRUITING

CHU d'Amiens

Amiens, 80054, France

NOT YET RECRUITING

CHU Lyon

Lyon, France

RECRUITING

MeSH Terms

Conditions

Neuralgia; Chronic Pain

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Philippe J Le Moine, MD

  CHRU of Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe J Le Moine, MD

CONTACT

+33298223956; philippe.lemoine@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: March 29, 2022
• Study Start: May 12, 2022
• Primary Completion (Estimated): May 12, 2027
• Study Completion (Estimated): September 12, 2027
• Last Updated: September 24, 2024

Record last verified: 2024-09

Locations

FR (20)