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Topical Analgesic

High-Dose vs Low-Dose Capsaicin for Neuropathic Pain

Phase 3
Recruiting
Research Sponsored by Averitas Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject has given written informed consent to participate.
Female or male subjects aged 18 years or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the baseline phase (day -7 to day -1) to visit 6 (week 12/day 84).
Awards & highlights

Study Summary

This trial is testing a new topical pain medication against a low-dose capsaicin control to see if it is more effective and safe in treating moderate to severe post-surgical neuropathic pain.

Who is the study for?
Adults aged 18+ with moderate to severe nerve pain following surgery, who can apply the treatment on intact skin and agree to use birth control if applicable. Excluded are those with confounding conditions like deep tissue pain, planned painful procedures during the trial, or surgeries related to cancer.Check my eligibility
What is being tested?
The trial is testing Qutenza (8% capsaicin) against a low-dose capsaicin (0.04%) for treating postsurgical neuropathic pain. Participants will be randomly assigned to either group in a double-blind manner, meaning neither they nor the researchers know who gets which treatment.See study design
What are the potential side effects?
Potential side effects may include local skin reactions such as irritation, redness, burning sensation at the application site; these are more common due to capsaicin's nature of causing a warming or tingling feeling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with chronic moderate to severe nerve pain.
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My skin area for treatment is healthy and smaller than 1120 cm2.
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I have had surgery that could cause persistent surgical pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the baseline phase (day -7 to day -1) to visit 6 (week 12/day 84).
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the baseline phase (day -7 to day -1) to visit 6 (week 12/day 84). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline to the weekly average score of Week 12 in the 24-hr average pain intensity.
Secondary outcome measures
Change from baseline to the average score of the entire period between Week 2 and Week 42 in the 24-hr average pain intensity.
Change from baseline to the weekly average score of Week 42 in the 24-hr average pain intensity.
Incidence of Treatment-Emergent Adverse Events (TEAEs) (Safety and tolerability)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Qutenza (capsaicin) 8% topical systemExperimental Treatment1 Intervention
Qutenza (capsaicin 8% topical system, containing capsaicin 179 mg or capsaicin 640 µg/cm2 of topical system)
Group II: Low-dose capsaicin controlActive Control1 Intervention
capsaicin 0.04% topical system

Find a Location

Who is running the clinical trial?

Averitas Pharma, Inc.Lead Sponsor

Media Library

Qutenza (capsaicin) 8% topical system (Topical Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT04967664 — Phase 3
Neuropathic Pain Research Study Groups: Qutenza (capsaicin) 8% topical system, Low-dose capsaicin control
Neuropathic Pain Clinical Trial 2023: Qutenza (capsaicin) 8% topical system Highlights & Side Effects. Trial Name: NCT04967664 — Phase 3
Qutenza (capsaicin) 8% topical system (Topical Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04967664 — Phase 3
Neuropathic Pain Patient Testimony for trial: Trial Name: NCT04967664 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do many hospitals in Canada offer this clinical trial?

"Currently, there are 30 clinical trial sites open for business, for example Neuroscience Research Center, LLC in Overland Park, Synergy Healthcare in Bradenton, and ILD Research Center in Vista."

Answered by AI

Could you please discuss the risks associated with using Qutenza (capsaicin) 8% topical system?

"Qutenza (capsaicin) 8% topical system is classified as a 3 in terms of safety. This is due to the fact that it is a Phase 3 trial, meaning that there is some evidence of its efficacy and multiple rounds of data supporting its safety."

Answered by AI

What are the main benefits of using Qutenza (capsaicin) 8% topical system?

"Qutenza (capsaicin) 8% topical system can be used to manage collagen diseases as well as acute nonspecific tenosynovitis, musculoskeletal pain, and muscle cramps."

Answered by AI

How many people can take part in this experiment at most?

"In order to carry out the planned research, 408 participants that fit the bill are needed. The clinical trial will be conducted by Averitas Pharma, Inc. at various locations, such as Synergy Healthcare in Bradenton, Florida and the Neuroscience Research Center, LLC in Overland Park, Kansas."

Answered by AI

Is there still room for new patients in this research project?

"The clinical trial is currently ongoing, as seen on clinicaltrials.gov. The study posted on 7/13/2021 and was last edited on 8/8/2022. They are looking for a total of 408 participants from 30 different sites."

Answered by AI

Is Qutenza (capsaicin) 8% topical system a new medication?

"Qutenza (capsaicin) 8% was initially studied in 2016 at Audie Lee Murphy VA Hospital. There are a total of 66 completed studies, with 10 more currently underway. A significant portion of these studies take place in Overland Park, Kansas."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Florida
What site did they apply to?
Synergy Healthcare
Other
International Spine, Pain, and Performance Center
Clinical Research of West Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+

Why did patients apply to this trial?

I have neuropathic pain from trigeminal Neuralgia. I'm having worsening neuropathic pain on toes on right foot. I have had previous surgery for broken right ankle.
PatientReceived 2+ prior treatments
I have tried drugs, acupuncture, physical therapy, injections and had nerve decompression surgery at my knee and nothing seems to work. My numbness and pain seem to be getting worse.
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. International Spine, Pain, and Performance Center: < 48 hours
Typically responds via
Phone Call
~111 spots leftby Mar 2025