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Comparison of Qutenza (8% Capsaicin) With a Low-dose Capsaicin for Treatment of Nerve Pain After Surgery

NCT04967664 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 409

Last updated 2026-04-17

No results posted yet for this study

Summary

This is an interventional, Phase III, double-blind, randomized, controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated topical application of Qutenza (capsaicin 8% topical system) versus low-dose capsaicin control (capsaicin 0.04% topical system) in subjects with moderate to severe postsurgical neuropathic pain (PSNP).

Conditions

  • Post Surgical Neuropathic Pain

Interventions

DRUG

Qutenza (capsaicin) 8% topical system

High concentration capsaicin

DRUG

capsaicin 0.04% topical system

Low-dose capsaicin control

Sponsors & Collaborators

  • Averitas Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-13
Primary Completion
2025-08-28
Completion
2025-08-28
FDA Drug
Yes

Countries

  • United States
  • France
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04967664 on ClinicalTrials.gov