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 study about?

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.

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Europejskie Centrum Leczenia Chorob Cywilizacyjnych	Warsaw	Poland
Medyczne Centrum Hetmanska	Poznan	Poland
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Medical Center Artmed Ltd.	Plovdiv	Bulgaria
Tomasz Blicharski Lubelskie Centrum Diagnostyczne	Swidnik	Poland
Spitalul Municipal Caracal	Caracal	Romania
Rcmed Oddzial Sochaczew	Sochaczew	Poland
Cxuuimi Mwxkhsj Df Dikunemmza Ss Thglkhfta Awdplbocn Nnjkhp Suighm	Brasov	Romania
Uovvabzsae Mglbfxvzxkck Hiqtxcoe Fel Amcihb Tqmifyhsn Sfpmi Gixpqp Eoq	Plovdiv	Bulgaria
Eee Nqphmsowzmdf Ssb z odgf	Warsaw	Poland
Maeqshedrqwdbqi Staedq	Ramnicu Valcea	Romania
Mloixvcmawv Thocghfnsmw Pdvulcd Eylq	Sofia	Bulgaria
Smggjwmb Cjhgxe &gpyxmqyyl Ik Caqfuglyxxxhxehzsv	Bucharest	Romania
Mwioeygvyrox Hekxuhcq Fps Ajqgsz Tggxmuiez Ezydgjzclomd Oqz	Varna	Bulgaria
Sggpb Mplre Hdmguyyr	Bucharest	Romania
Stzo Mlyhoqvint Setkun	Bucharest	Romania
Mjfykdq Czsmmf Saizaga Sgasz Exlp	Sofia	Bulgaria
Eovir Ojwxclr Bhglx Kptoyyjpiub Tanpve Ppyfd Sxyahb	Olsztyn	Poland
Mxybqcopvvllyuur Stwbow	Timisoara	Romania
Cqokyhwaz Dbqzdqt Nsdrc Snu ks	Bialystok	Poland
Pnpajqukvoq Cnsr Svqnyt	Bucharest	Romania
Pbi Zllnffm Sibw	Kielce	Poland
Zqrtbo Owsplc Zhmtlqmbhq W Bumqzqzpej	Boleslawiec	Poland
Cudvfiwps Keuvwa Ssq z otyf	Cracow	Poland
Cfrxrru Kjcsswntuofpleplyl Jxbctuvutjg Bxvzqachhfktpbmjokhsqdoy Lyvpbdj semgr	Elblag	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	18.08.2022
Poland	Not recruiting	18.08.2022
Romania	Not recruiting	18.08.2022

Trial locations

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.

Investigated Diseases:

Osteoarthritis

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.

Trial ID:

2024-515709-24-00

Protocol code:

KF7039-03

NCT ID:

NCT05377489

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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