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Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children

Study acronym: CAPSAPED
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary and study completion dates: Apr 5, 2026 to Jul 5, 2028
    • Study sites revised (10)
    v9
  2. Re-verified, no change to tracked fieldsv8
  3. Phase: Phase 2 to Phase 3
    • Site details revised at 7 of 10 sites
    v7
  4. Study sites revised (10)v6
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Apr 1, 2026 to Apr 5, 2026
    • Start date changed from estimate of Feb 1, 2024 to Mar 5, 2024
    • Site details revised at 10 of 10 sites
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Dec 1, 2023 to Feb 1, 2024
    • Study sites revised (10)
    v4
  2. Start date: Oct 1, 2023 to Dec 1, 2023
    • Primary and study completion dates: Feb 1, 2026 to Apr 1, 2026
    v3
  3. Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 9 entries
    • Study description revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05997979
Lead Sponsor University Hospital, Brest
Conditions
(from sponsor)		 Neuropathic Pain, Chronic Pain
Related terms Chronic Pain, Neuralgia
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov