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Resiniferatoxin for Chronic Pain
Study Summary
This trial is testing whether the research drug RTX is safe and can reduce cancer-induced bone 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 am willing to stop or adjust my medication as advised before surgery.You should not have any spinal cord or spinal space issues that could make it risky to insert a needle.Your electrolyte levels must be normal or can be fixed.I haven't had a fever or any signs of infection in the last week.My main pain source is not located above my mid-chest area.I am not planning any cancer treatment until after the first two weeks of the study.I am not planning to change my current cancer treatment before the two-week mark.I am willing and able to have an eye exam.I understand and can agree to the study's procedures and risks.I have someone to help me with daily tasks until Day 14 of the visit.I can assign someone to make decisions for me for research and medical care.I have never had heart failure or unexplained fainting.I haven't been in a drug/device trial within the last 30 days nor plan to start one within 14 days of RTX injection.I am 18 years old or older.Your heart's electrical activity should not show a QTc interval longer than 450 milliseconds.I experience moderate to severe pain that regular treatments don't relieve.My family does not have a history of long QT syndrome.I am not currently undergoing any treatments intended to cure my cancer.I agree to a pain relief injection that must reduce my pain by at least 30%.I do not have moderate to severe pain from causes other than my cancer or its treatment.I am willing to use effective birth control during the study.I am not pregnant or breastfeeding.You should not have any blood clotting or bleeding issues based on recent blood tests.I have not undergone any invasive nerve treatments.I have severe cancer-related pain in my mid-body to legs that doesn't get better with usual treatments.
- Group 1: Resiniferatoxin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any available slots in this trial for participants?
"Clinicaltrials.gov confirms that this medical study, which was initially posted on the 1st of January 2023 and last updated November 18th 2022, is not actively looking for enrollees at present. However, there are 60 other trials in progress right now seeking participants."
Are there additional investigations into Resiniferatoxin's effects?
"Currently, 4 clinical trials are ongoing concerning the use of Resiniferatoxin. None of these studies have advanced to Phase 3 yet. Despite being primarily administered in Bethesda, Maryland, 11 other sites also offer this treatment option as part of their research."
How many volunteers are participating in this clinical trial?
"At the moment, this trial is not currently enrolling patients. It was initially posted on January 1st 2023 and its information last updated on November 18th 2022. If you're searching for other studies, there are 56 different clinical trials related to pain that are actively recruiting participants as of now; additionally, 4 Resiniferatoxin-related experiments have open spots available."
Do I meet the requirements to partake in this exploration?
"This clinical trial actively seeks 30 patients aged 18 or over with intractable, cancer-induced pain in their mid thoracic or lower body who have not responded to conservative therapies (i.e., analgesics, radiotherapy, bisphosphonates). Participants must be healthy enough to tolerate study procedures and abstain from taking aspirin, prophylactic anticoagulants such as Coumadin, heparin or Xarelto for at least seven days prior to surgery. In addition, any individuals currently taking a Factor Xa inhibitor will need an additional haematology consultation. Furthermore candidates cannot undergo curative"
Is this a novel clinical trial?
"At present, 4 clinical trials for Resiniferatoxin are running across 7 cities in 1 nation. The initial trial began back in 2009 and was sponsored by Sorrento Therapeutics, Inc. This phase-one drug approval included 45 participants and since then two additional studies have been conducted."
Is enrollment open to individuals over thirty years of age in this experiment?
"According to the trial's requirements, individuals aged 18 - 150 are eligible for participation."
What desired effects are the investigators hoping to observe from this research trial?
"This medical trial's main purpose is to evaluate the safety and toxicity of a given treatment. Secondary objectives include a 20% decrease in pain intensity at 30, 60, 90, and 180 days post-treatment when compared to baseline scores; an increase in quality of life via the Brief Pain Inventory (BPI); and substantially reduced concomitant opioid analgesic consumption per NRS daily worst score estimates."
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