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High-Dose vs Low-Dose Capsaicin for Neuropathic Pain
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had surgery that could cause persistent surgical pain.I agree to follow the treatment rules and either am not on pain medication for nerve pain or have been on a stable dose for over 30 days.I have moderate to severe pain, averaging at least 4 out of 10 in the last week.My skin area for treatment is healthy and smaller than 1120 cm2.I have had surgery-related pain for 6 to 60 months, and it spreads beyond the scar.I have been diagnosed with probable or definite nerve pain following the specific criteria.I have severe pain from nerve damage and no planned painful procedures.I have not had surgery for cancer, chronic pain conditions, or nerve issues.I have been diagnosed with chronic moderate to severe nerve pain.I am 18 years old or older.
- Group 1: Qutenza (capsaicin) 8% topical system
- Group 2: Low-dose capsaicin control
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- International Spine, Pain, and Performance Center: < 48 hours
Typically responds via
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