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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500265-27-00

Acronym

29BRC21.0184

Enrollment

Registered

2023-07-31

Start date

2024-03-05

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic postchirurgical or post-traumatic neuropathic pain

Brief summary

Difference in Neuropathic Pain Symptom Inventory score evaluated between the first application (M0) of capsaicin or placebo and 4 months later (M4).

Detailed description

Adverse event monitoring are collected during patch application and by phone calls in the following days., Vital signs including cardiac frequency and arteriel pressure., Physical examination including dermal assessment, Intake of rescue medication against pain (YES/NO), Duration of patch application, Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome, Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome

Interventions

DRUGQutenza 179 mg cutaneous patch

DRUGComfeel plus transparent (hydrocolloid dressing): a medical device classe iib. Details are specified in the protocol and the cover letter (2nd pragraph). a ticket is open in the desk service (sd-729570)

DRUGTramadol 100 mg/ml oral drops

DRUGsolution

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Difference in Neuropathic Pain Symptom Inventory score evaluated between the first application (M0) of capsaicin or placebo and 4 months later (M4).	—

Secondary

Measure	Time frame
Adverse event monitoring are collected during patch application and by phone calls in the following days., Vital signs including cardiac frequency and arteriel pressure., Physical examination including dermal assessment, Intake of rescue medication against pain (YES/NO), Duration of patch application, Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome, Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome	—

Measure

Time frame

—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026