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Study on the Safety of RTX-GRT7039 and Ropivacaine Hydrochloride Injections for Patients with Moderate to Severe Knee Osteoarthritis Pain

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for osteoarthritis of the knee, which is a condition that causes moderate to severe pain in the knee joint. The treatment being tested is called RTX-GRT7039, which contains a substance known as resiniferatoxin. This treatment is administered through an injection directly into the knee joint. The study also involves the use of another medication called Naropin, which contains ropivacaine hydrochloride, a substance commonly used to numb the area and reduce pain during the procedure.

The purpose of this study is to evaluate the safety and tolerability of the RTX-GRT7039 injections in individuals experiencing knee pain due to osteoarthritis. Participants in the study will receive these injections and will be monitored over a period of time to observe any side effects or changes in their condition. The study aims to gather information on how well the treatment is tolerated and whether it causes any adverse effects.

Throughout the study, participants will undergo various assessments, including imaging tests like X-ray and MRI scans, to check for any structural changes in the knee joint. Additionally, questionnaires will be used to evaluate changes in physical function, pain levels, and overall quality of life. The study is designed to provide valuable insights into the potential benefits and risks of using RTX-GRT7039 for managing knee pain associated with osteoarthritis.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, eligibility is confirmed based on criteria such as age, body mass index, and diagnosis of osteoarthritis of the knee.
The trial is designed for individuals with moderate to severe knee pain who have not found sufficient relief from standard treatments.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current state of knee pain and physical function.
This includes completing questionnaires like the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and quality of life assessments using EQ-5D-5L and SF-36.
Step 3
First medication administration
The first medication, RTX-GRT7039, is administered through an intra-articular injection directly into the knee joint.
This is a concentrate and solvent for solution for injection, specifically targeting pain relief.
Step 4
Second medication administration
A second medication, Naropin® 5 mg/ml, is also administered via intra-articular injection.
This solution for injection is used to manage pain associated with osteoarthritis.
Step 5
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor the safety and tolerability of the medications.
These visits include assessments for any treatment-emergent adverse events and changes in knee joint structure using imaging methods like X-ray or MRI.
Step 6
Evaluation of outcomes
The primary outcome is the incidence of adverse events related to the treatment.
Secondary outcomes include changes in physical function and pain scores, as well as quality of life improvements.
Step 7
Completion of trial
The trial is expected to conclude by March 12, 2025.
Final assessments will determine the overall safety and effectiveness of the treatment for knee osteoarthritis pain.

Who can join the trial?

6 criteria

Must be **18 years or older** at the time of the screening visit.
Must have a **Body Mass Index (BMI)** of **40.0 kg/m² or less**. BMI is a measure that uses your height and weight to work out if your weight is healthy.
Must have a **diagnosis of osteoarthritis of the knee**. This diagnosis should be based on specific criteria from the American College of Rheumatology, and the person should have a functional capacity class of I-III, which refers to their ability to perform daily activities.
Must have **moderate to severe osteoarthritis** at the start of the study.
Must have a **documented history** showing that the person has not had enough pain relief with the best standard treatments available.
The study investigator must believe that no additional benefit can be expected from further changes to the person's pain treatment.

Who cannot join the trial?

10 criteria

Patients who have any other significant health issues that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery on the knee.
Patients who have an allergy to any of the study medications.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have an infection in the knee area.
Patients who have a history of certain heart conditions.
Patients who have uncontrolled high blood pressure.
Patients who have a history of certain mental health conditions.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Verified
Brasov, Romania
Clinicmed Daniluk Nowak Sp. k.
Verified
Bialystok, Poland
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Responsive
Plovdiv, Bulgaria

Trial locations

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Investigated drugs

RTX-GRT7039 is an investigational medication being studied for its potential to relieve moderate to severe pain in people with osteoarthritis of the knee. It is administered through injections directly into the joint, which is known as intra-articular injection. The main goal of the trial is to determine how safe and well-tolerated this medication is for patients experiencing knee pain due to osteoarthritis.

What is already known about the treatment

RTX-GRT7039 – This medication is administered through intra-articular injections, meaning it is injected directly into the joint space. It is currently being studied in a Phase III clinical trial to evaluate its safety and tolerability for treating moderate to severe pain associated with osteoarthritis of the knee. The main therapeutic indication is pain relief for osteoarthritis patients. RTX-GRT7039 works by targeting specific pain pathways at the molecular level, potentially reducing pain signals. It is classified pharmacologically as an analgesic, which is a type of medication used to relieve pain.

Investigated diseases

Osteoarthritis of the knee – Osteoarthritis of the knee is a degenerative joint disease characterized by the breakdown of cartilage in the knee joint. This condition leads to pain, swelling, and stiffness, making movement difficult. Over time, the cartilage wears away, causing bones to rub against each other, which can result in further pain and joint damage. The disease progresses gradually, often worsening with age and activity. It can lead to decreased range of motion and may cause the formation of bone spurs. The severity of symptoms can vary, with some individuals experiencing mild discomfort and others facing significant mobility challenges.