NCT04967664

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

An Interventional, Phase III, Double-blind, Randomized, Controlled, Parallel-group, Multi-site, Clinical Trial Evaluating the Efficacy and Safety of Qutenza® in Subjects With Post-surgical Neuropathic Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 409 (actual)
• Sponsor: Averitas Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

After a Screening Period of up to 19 days, including the Baseline Phase from Day -7 to Day -1, subjects will be allocated to Qutenza or to low-dose capsaicin control topical system (capsaicin 0.04%) at the Randomization Visit. The blinded Treatment Period consists of a Core Phase (Day 1 to Week 12) and an Extension Phase (Week 13 to Week 42), which includes a Follow-up of 14 days

Conditions

• Post Surgical Neuropathic Pain

Interventions

Type	Name	Description
DRUG	Qutenza (capsaicin) 8% topical system	High concentration capsaicin
DRUG	capsaicin 0.04% topical system	Low-dose capsaicin control

Timeline

• Start date: 2021-07-13
• Primary completion: 2025-08-28
• Completion: 2025-08-28
• First posted: 2021-07-19
• Last updated: 2026-04-17

Locations

64 sites across 6 countries: United States, France, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study