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New knee shot could ease arthritis pain without surgery

NCT ID NCT05248386

Symptom relief Sponsor: Grünenthal GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested an experimental drug called RTX-GRT7039, given as an injection into the knee joint, to see if it reduces pain from osteoarthritis. 469 adults with knee osteoarthritis who did not get enough relief from standard treatments took part. The study compared the drug to a placebo injection to measure pain changes over 12 and 26 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RTX-GRT7039 (an experimental drug injected into the knee joint)
What this could lead to
If it works, this could provide a new option for easing knee osteoarthritis pain without surgery.
What could go wrong
This is a completed Phase 3 trial, but results are not yet public. The drug may not prove more effective than placebo, and injections carry risks like infection or joint pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

469 people

The number who actually took part.

Started

Aug 2022

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The participant has given written informed consent to participate. * The participant is 18 years of age or older at the Screening Visit. * The participant has a diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I to III. * There is a documented history indicating that participant has insufficient pain relief with previous Standard of Care. Exclusion Criteria: * The participant has past joint replacement surgery of the index knee. * The participant has a history of significant trauma or surgery (e.g., open or arthroscopic) to the index knee within 12 months of Screening. * The participant has periarticular pain from any cause other than osteoarthritis, including referred pain, bursitis, or tendonitis. * The participant has clinical hip osteoarthritis on the side of the index knee. * The participant has pre-existing osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, severe bone on bone osteoarthritis, knee pain attributable to disease other than osteoarthritis, or the participant has rapidly progressing osteoarthritis (RPOA) Type I or Type II. * The participant has significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus \>10, valgus \>10) by X-ray as assessed by independent Central Readers at Screening Visit. * The participant has other conditions that could affect trial endpoint assessments of the index knee. * The participant has current clinically significant disease(s) or condition(s) that may affect efficacy or safety assessments, or any other reason which, in the investigator's opinion, may preclude the participant's participation for the full duration of the trial. * The participant has a history of hypersensitivity to resiniferatoxin (RTX) or any similar component (capsaicin, chili peppers). * The participant is currently participating or was participating in another investigational drug trial within 3 months prior to the Screening Visit. * The participant is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site or is a family member of the employees or the investigator.

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoarthritis

Contacts and locations

Locations

  • AOU Citta della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • AOU-Careggi

    Florence, 50134, Italy

  • AOU-Careggi

    Florence, 50139, Italy

  • Aggarwal and Associates Limited

    Brampton, Ontario, L6T 0G1, Canada

  • AmBeNet, Practice Dr. Dr. med. Hans-Detlev Stahl

    Leipzig, 04107, Germany

  • CCBR Czech Prague, s.r.o

    Prague, 130 00, Czechia

  • CCR Prague, s.r.o

    Prague, 130 00, Czechia

  • CHU Amiens Nord

    Amiens, 80054, France

  • CHU Nimes Cedex

    Nîmes, 30029, France

  • CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.

    Mexico City, Mexico City, 11850, Mexico

  • Centre Hospitalier Universitaire d'Amiens-Picardie - Site Sud

    Amiens, 80000, France

  • Centro Integral en Reumatologia, SA de CV

    Guadalajara, Jalisco, 44160, Mexico

  • Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C.

    Culiacán, Sinaloa, 80000, Mexico

  • Centrum Medyczne Kuba-Med Zamosc

    Zamość, 22400, Poland

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081, Poland

  • Centrum fuer Diagnostik und Gesundheit (CDG)

    München, 80809, Germany

  • Clinstile, S.A. de C.V

    Cuauhtémoc, Mexico City, 06700, Mexico

  • Cochin Hospital-Paris Descartes University

    Paris, 75014, France

  • Consultorio de Reumatologia

    Gustavo Adolfo Madero, Mexico City, 07760, Mexico

  • Cook Street Medical Clinic

    Victoria, British Columbia, V8V 4A1, Canada

  • Db Ortopedie s.r.o

    Příbram, 26101, Czechia

  • Diex Recherche Victoriaville Inc.

    Victoriaville, Quebec, G6P 6P6, Canada

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1L 0H8, Canada

  • Dipartimento Di Scienze Ortopediche, Traumatologiche, Riabilitative E Plastico-Ricostruttive

    Naples, 80138, Italy

  • Dr. M. B. Jones

    Victoria, British Columbia, V9V 4A1, Canada

  • Dr. Miguel Cortes Hernandez MD, Office of

    Cuernavaca, Morelos, 62448, Mexico

  • EUC Klinika

    Prague, 15000, Czechia

  • Fakultni Thomayerova nemocnice s poliklinikou

    Prague, 140 59, Czechia

  • Funabashi Municipal Medical Center

    Funabashi-shi, Chiba, 273-8588, Japan

  • GRMO (Groupe de Recherche en Rhumatologie et Maladies Osseuses) Inc.

    Sainte-Foy, Quebec, G1V 3M7, Canada

  • Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

    Bialystok, Podlaskie Voivodeship, 15-077, Poland

  • HRF Hamburger Rheuma Forschungszentrum

    Hamburg, 20095, Germany

  • Hakodate Central General Hospital

    Hakodate, Hokkaido, 040-8585, Japan

  • Hamanomachi Hospital

    Fukuoka, Fukuoka, 810-8539, Japan

  • Hopital Edouard Herriot

    Lyon, 69437, France

  • Hopital Lariboisiere,Hospitalier Universitaire Nord

    Paris, 75475, France

  • Hopital Saint antoine

    Paris, 75012, France

  • Hopitaux de Paris (AP-HP) - Groupe Hospitalier Cochin -Assistance Publique

    Paris, 75014, France

  • INTER CLINIC Piotr Adrian Klimiuk

    Bialystok, 15-077, Poland

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Interni A Revmatologicka Ambulance

    Břeclav, 690 02, Czechia

  • Investigacion y Biomedicina de Chihuahua

    Chihuahua City, 31000, Mexico

  • Japan Organization of Occupational Health and Safety Yokohama Rosai Hospital

    Yokohama, Kanagawa, 222-0036, Japan

  • Japanese Red Cross Hamamatsu Hospital

    Hamamatsu, Shizuoka, 434-8533, Japan

  • Juntendo University Graduate School of Medicine

    Bunkyo-ku, Tokyo, 113-0034, Japan

  • Juntendo University Hospital

    Bunkyo-Ku, Tokyo, 113-0033, Japan

  • Juntendo University Hospital

    Tokyo, 113-8431, Japan

  • KKR Sapporo Medical Center

    Sapporo, Hokkaido, 062-0931, Japan

  • KKR Tohoku Kosai Hospital

    Sendai, Miyagi, 980-0803, Japan

  • KKR Tohoku Kosai Hospital

    Aoba-ku, Sendai-shi, 980-0803, Japan

  • KO-MED Centra Kliniczne Lublin II

    Zamość, Lublin Voivodeship, 20-362, Poland

  • KO-MED Centra Kliniczne Lublin II

    Lublin, 20-362, Poland

  • Kamagaya General Hospital

    Kamagaya, Chiba, 273-0121, Japan

  • Kinashi Obayashi Hospital

    Takamatsu, Kagawa-ken, 761-8024, Japan

  • Kitasato University Kitasato Institute Hospital

    Minato-ku, Tokyo, 108-8642, Japan

  • Kosei General Hospital

    Mihara, Hiroshima, 370-0115, Japan

  • Kosei General Hospital

    Mihara-shi, Hiroshima, 723-8686, Japan

  • Lekarna U Svate Anny

    Písek, Czech Republic, 397 01, Czechia

  • Makmed Nzoz

    Nadarzyn, Masovian Voivodeship, 05-830, Poland

  • Malopolskie Centrum Kliniczne

    Krakow, 30-149, Poland

  • Malton Medical Research

    Mississauga, Ontario, L4V 1P1, Canada

  • Marunouchi Hospital

    Matsumoto, Nagano, 390-0841, Japan

  • Mazowieckie Centrum Badan Klinicznych

    Grodzisk Mazowiecki, 05-825, Poland

  • Medical Corporation Teda Ooimachi Orthopaedic Surgery and Surgery Clinic

    Tokyo, 140-0014, Japan

  • Medisch Spectrum Twente (MST) - Enschede Haaksbergerstraat

    Enschede, KZ, 7512 KZ, Netherlands

  • Medizentrum Essen Borbeck

    Essen, 45355, Germany

  • Morales Vargas Centro de Investigacion SC

    León, Guanajuato, 37000, Mexico

  • NZOZ Lecznica MAK-MED S.C.

    Nadarzyn, Masovian Voivodeship, 05-830, Poland

  • Nakajo Orthopedic Clinic

    Sendai, Miyagi, 983-0862, Japan

  • Ortho-Zentrum Karlsruhe

    Karlsruhe, 76133, Germany

  • Ortopedicko-traumatologicka ambulance

    Písek, 397 01, Czechia

  • Otsu City Hospital

    Ōtsu, Shiga, 520-0804, Japan

  • PT&R

    Beek, Limburg, 6191 JW, Netherlands

  • PV-MEDICAL s.r.o. Revmatologicka ambulance

    Zlín, 760 01, Czechia

  • Pratia MCM Krakow

    Krakow, Lesser Poland Voivodeship, 30-727, Poland

  • Praxis Dr. med. Stephan Grunert

    Eichstätt, 85072, Germany

  • Praxis-Reinfeld-Mitte

    Reinfeld, 23858, Germany

  • Reumed Spolka z o.o. Zespol poradni Specjalistycznych Filia Nr 1 Wallenroda

    Lublin, Lublin Voivodeship, 20-607, Poland

  • Revmatologicka Ambulance

    Ostrava, 70200, Czechia

  • Revmatologicka ambulance

    Prague, 140 00, Czechia

  • Revmatologicka ambulance

    Prague, 14000, Czechia

  • Revmatologie s.r.o.

    Brno, 63800, Czechia

  • Sapporo Maruyama Orthopedic Hospital

    Sapporo, Hokkaido, 060-0007, Japan

  • Sapporo kotoni Orthopedies

    Sapporo, Hokkaido, 0630814, Japan

  • Seiwa-kai medical corporation Hiroshima clinic

    Hiroshima, Hiroshima, 733-0032, Japan

  • Shimane University Hospital

    Izumo, Shimane, 693-0021, Japan

  • Shimane University Hospital

    Izumo, Shimane, 693-8501, Japan

  • Shirahama Hamayu Hospital

    Nishimura, Wakayama, 649-2211, Japan

  • Social Medical Care Corporation Hosei-kai Marunouchi Hospital

    Nagano, Matsumoto-shi Nagano, 390-8601, Japan

  • Souseikai Fukuoka Mirai Hospital

    Fukuoka, Fukuoka, 813-0017, Japan

  • Spaarne Gasthuis (Kennemer Gasthuis)

    Hoofddorp, 2134 TM, Netherlands

  • St Centrum Medyczne Plejady

    Krakow, 30-363, Poland

  • Synexus Gdynia

    Gdynia, 81-537, Poland

  • Synexus Katowice Medical Center

    Katowice, 40-040, Poland

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, Pomeranian Voivodeship, 80-382, Poland

  • Synexus Polska Sp. z o.o. Oddzial w Lodzi

    Lodz, 90-127, Poland

  • Synexus Polska Spolka z ograniczona odpowiedzialnoscia Oddzial we Wroclawiu

    Wroclaw, 50-381, Poland

  • Synexus Poznan Medical Center

    Poznan, Greater Poland Voivodeship, 60-702, Poland

  • Thomayerova Nemocnice (TN)

    Prague, 140 00, Czechia

  • Universita degli Studi della Campania Luigi Vanvitelli - Azienda Ospedaliera Universitaria

    Naples, 80138, Italy

  • Velocity Clinical Research Leipzig GmbH

    Leipzig, 04103, Germany

  • Vesalion s.r.o.

    Ostrava, 702 00, Czechia

  • Yokohoma Rosai Hospital

    Yokohama, Kanagawa, 222-0036, Japan

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