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Resiniferatoxin for Osteoarthritis
Study Summary
This trial evaluates whether a single injection of a medication called RTX can reduce pain for people with moderate to severe osteoarthritis knee pain, compared to placebo.
- Osteoarthritis of the Knee
- Osteoarthritis
- Chronic Knee Pain
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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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- You have significant knee pain caused by osteoarthritis, as determined by your doctor using specific guidelines from the American College of Rheumatology.Your knee is not stable or properly aligned after previous surgery or repair.You have a past of drug or alcohol abuse.You have a knee x-ray or MRI scan with KL grade ≥ 2 in the index knee.You have tried at least two pain medications before, including one NSAID, but they did not work well enough or caused side effects that led to stopping the treatment.You have a lot of pain in your knee that is caused by osteoarthritis. The doctor will use the American College of Rheumatology criteria to determine the severity of your pain.You have tried at least two pain medications before (including one NSAID) but had to stop because they didn't work well or caused side effects.You have tried at least two different pain medications (including one NSAID) but they didn't work well enough or caused too many side effects.You have severe pain in other parts of your body that makes it hard to accurately measure the pain in your knee.You experience moderate to severe pain (rated as 4 or higher on a scale of 0 to 10) while walking for most of the days in the week before the screening.You are allergic or have a strong reaction to capsaicin, chili peppers, lidocaine, or resiniferatoxin.You have been experiencing knee pain for at least 6 months before the screening.You have significant pain in your knee caused by arthritis, as determined by the doctor using specific criteria from the American College of Rheumatology.Your average walking pain score in the past week is 4 or higher on a scale from 0 to 10.You have metal implants or other objects in your knee that cannot be removed.Your knee has been hurting for at least 6 months before the screening.You have experienced knee pain due to osteoarthritis for at least 6 months before the screening.You are willing to abstain from other IA injections or knee surgery for at least 6 months after study treatment unless you elect early discontinuation from the study.
- Group 1: Resiniferatoxin
- Group 2: Zilretta
- Group 3: Placebo
- 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
How many participants are included in the research cohort for this clinical trial?
"Indeed, the information accessible via clinicaltrials.gov points to this trial being open for recruitment. Originally made public on November 15 2021, the study was recently updated on September 22 2022 and is searching for 112 patients from 6 different medical centres."
Has Resiniferatoxin been granted sanction by the FDA?
"There is existing clinical evidence that suggests the safety of Resiniferatoxin, thus it has been rated a 2 on our scale. However, there are no data points supporting its efficacy for this Phase 2 trial."
What prior experiments have been done to assess the efficacy of Resiniferatoxin?
"Resiniferatoxin was first investigated in 2005 by Hamid Ahmadieh, MD. Since then an abundance of studies have been completed - 18505 to be exact - and 44 are currently enrolling participants primarily from La Mesa, Illinois."
Can individuals currently participate in this research initiative?
"Clinicaltrials.gov attests that this medical trial, which was first made available on November 15th 2021, is currently recruiting patients. The posting has been modified most recently on September 22nd 2022."
To what ailment does Resiniferatoxin typically offer a remedy?
"Resiniferatoxin is a common pharmaceutical approach to treating ulcerative colitis, as well as hand and brain maladies, along with some dermatologic disorders."
Are there a considerable number of sites in the US running this clinical trial?
"At present, 6 clinical sites are enrolling patients into this trial. These medical centres are located in La Mesa, Oak Brook and Carrollton with other 3 locations scattered across the country. To minimize travel requirements for participants, it is suggested to select the closest site when signing up for the study."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Affinity Health: < 24 hours
- Lotus Clinical Research: < 48 hours
Average response time
- < 2 Days
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