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NCT04967664 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Post Surgical Neuropathic Pain, sponsored by Averitas Pharma.

Completed
Registry status
Phase 3
Development phase
409
Enrollment target
20
Study locations

NCT04967664: Completed Phase 3 study of Post Surgical Neuropathic Pain, sponsored by Averitas Pharma.

NCT04967664 is a Phase 3 study of Post Surgical Neuropathic Pain that has completed, run by Averitas Pharma. The registered enrollment target is 409 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04967664, a Phase 3 study of Post Surgical Neuropathic Pain, has completed, sponsored by Averitas Pharma.

COMPLETED
Registry status
Phase 3
Development phase
409 participants
Enrollment target
20
Study locations

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).

Primary Outcome

For the US. The 24-hr average pain intensity will be assessed and reported in the electronic diary (e-diary) once daily in the evening, using an 11-point numeric pain rating scale (NPRS, from 0 = no pain to 10 = pain as bad as you can imagine).

Interventions

  • DRUG Qutenza (capsaicin) 8% topical system
  • DRUG capsaicin 0.04% topical system

Study Locations (20)

Florida

  • South Lake Pain Institute - Clermont
  • University Clinical Research - DeLand Clinical Research Unit - DeLand
  • Florida Research Center, Inc. - Miami
  • Clinical Research of West Florida - Tampa

Kansas

  • Neuroscience Research Center, LLC - Overland Park
  • Kansas City Bone & Joint Clinic, P.A. - Overland Park

North Carolina

  • Accellacare - Wilmington
  • The Center for Clinical Research - Winston-Salem

Arizona

  • Tucson Orthopaedic Institute - Tucson

California

  • ILD Research Center - Vista

District of Columbia

  • International Spine, Pain, and Performance Center - Washington D.C.

Georgia

  • Drug Studies America - Marietta

Illinois

  • Rush University Medical Center - Chicago

Trial Details

FieldValue
Enrollment Target 409 participants
Start Date 2021-07-13
Est. Completion 2025-08-28
Phase Phase 3
Averitas Pharma

2 total trials

What the finished NCT04967664 record still lists

NCT04967664 is an interventional study that assigns participants to a tested intervention. The registered 409 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).

The record links to 1 condition, with Post Surgical Neuropathic Pain appearing as the primary indexed condition, and to 2 interventions - of which Qutenza (capsaicin) 8% topical system is the first listed.

NCT04967664 names 20 study sites across 15 states, led by Florida, Kansas, North Carolina.

Frequently Asked Questions

What is clinical trial NCT04967664 about?

NCT04967664 is a clinical study titled "Comparison of Qutenza (8% Capsaicin) With a Low-dose Capsaicin for Treatment of Nerve Pain After Surgery". 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 sub...

What is the current status of trial NCT04967664?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 409 participants. The study started on 2021-07-13. Estimated completion is 2025-08-28.

What conditions does trial NCT04967664 study?

This clinical trial studies the following conditions: Post Surgical Neuropathic Pain.

What interventions are being tested in trial NCT04967664?

The interventions under investigation include: Qutenza (capsaicin) 8% topical system (DRUG), capsaicin 0.04% topical system (DRUG).

Who is sponsoring clinical trial NCT04967664?

This trial is sponsored by Averitas Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04967664 being conducted?

This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04967664's enrollment target sits among peer trials

409 911th of 2000 higher than 1,090 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04967664, the US trial registry maintained by the National Library of Medicine. NCT04967664 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.