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OsteoarthritisPhase 3NCT05248386

Efficacy and Safety of RTX-GRT7039 in Adult Subjects With Knee Osteoarthritis

A Phase 3 study testing RTX-GRT7039 in people with Osteoarthritis, run by Grünenthal GmbH at 103 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated injections of RTX-GRT7039 versus placebo in patients who have pain associated with osteoarthritis of the knee despite standard of care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
RTX-GRT7039
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
469 participants
Where
103 sitesin 9 countries
Study dates
26 Aug 2022to 18 Nov 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

103 sites in 9 countries.

103 sites in 9 countries

Japan29 sites

  • KKR Tohoku Kosai Hospital

    Aoba-ku, Sendai-shi, 980-0803

  • Juntendo University Graduate School of Medicine

    Bunkyo-ku, Tokyo, 113-0034

  • Juntendo University Hospital

    Bunkyo-Ku, Tokyo, 113-0033

  • Hamanomachi Hospital

    Fukuoka, Fukuoka, 810-8539

  • Souseikai Fukuoka Mirai Hospital

    Fukuoka, Fukuoka, 813-0017

  • Funabashi Municipal Medical Center

    Funabashi-shi, Chiba, 273-8588

  • Hakodate Central General Hospital

    Hakodate, Hokkaido, 040-8585

  • Japanese Red Cross Hamamatsu Hospital

    Hamamatsu, Shizuoka, 434-8533

  • Seiwa-kai medical corporation Hiroshima clinic

    Hiroshima, Hiroshima, 733-0032

  • Shimane University Hospital

    Izumo, Shimane, 693-0021

  • Shimane University Hospital

    Izumo, Shimane, 693-8501

  • Kamagaya General Hospital

    Kamagaya, Chiba, 273-0121

  • Marunouchi Hospital

    Matsumoto, Nagano, 390-0841

  • Kosei General Hospital

    Mihara, Hiroshima, 370-0115

  • Kosei General Hospital

    Mihara-shi, Hiroshima, 723-8686

  • Kitasato University Kitasato Institute Hospital

    Minato-ku, Tokyo, 108-8642

  • Social Medical Care Corporation Hosei-kai Marunouchi Hospital

    Nagano, Matsumoto-shi Nagano, 390-8601

  • Shirahama Hamayu Hospital

    Nishimura, Wakayama, 649-2211

  • Otsu City Hospital

    Ōtsu, Shiga, 520-0804

  • Sapporo Maruyama Orthopedic Hospital

    Sapporo, Hokkaido, 060-0007

  • KKR Sapporo Medical Center

    Sapporo, Hokkaido, 062-0931

  • Sapporo kotoni Orthopedies

    Sapporo, Hokkaido, 0630814

  • KKR Tohoku Kosai Hospital

    Sendai, Miyagi, 980-0803

  • Nakajo Orthopedic Clinic

    Sendai, Miyagi, 983-0862

  • Kinashi Obayashi Hospital

    Takamatsu, Kagawa-ken, 761-8024

  • Juntendo University Hospital

    Tokyo, 113-8431

  • Medical Corporation Teda Ooimachi Orthopaedic Surgery and Surgery Clinic

    Tokyo, 140-0014

  • Japan Organization of Occupational Health and Safety Yokohama Rosai Hospital

    Yokohama, Kanagawa, 222-0036

  • Yokohoma Rosai Hospital

    Yokohama, Kanagawa, 222-0036

Other trials in Japan

Poland19 sites

  • Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

    Bialystok, Podlaskie Voivodeship, 15-077

  • INTER CLINIC Piotr Adrian Klimiuk

    Bialystok, 15-077

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

    Gdansk, Pomeranian Voivodeship, 80-382

  • Synexus Gdynia

    Gdynia, 81-537

  • Mazowieckie Centrum Badan Klinicznych

    Grodzisk Mazowiecki, 05-825

  • Synexus Katowice Medical Center

    Katowice, 40-040

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081

  • Pratia MCM Krakow

    Krakow, Lesser Poland Voivodeship, 30-727

  • Malopolskie Centrum Kliniczne

    Krakow, 30-149

  • St Centrum Medyczne Plejady

    Krakow, 30-363

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

    Lodz, 90-127

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

    Lublin, Lublin Voivodeship, 20-607

  • KO-MED Centra Kliniczne Lublin II

    Lublin, 20-362

  • Makmed Nzoz

    Nadarzyn, Masovian Voivodeship, 05-830

  • NZOZ Lecznica MAK-MED S.C.

    Nadarzyn, Masovian Voivodeship, 05-830

  • Synexus Poznan Medical Center

    Poznan, Greater Poland Voivodeship, 60-702

  • Synexus Polska Spolka z ograniczona odpowiedzialnoscia Oddzial we Wroclawiu

    Wroclaw, 50-381

  • KO-MED Centra Kliniczne Lublin II

    Zamość, Lublin Voivodeship, 20-362

  • Centrum Medyczne Kuba-Med Zamosc

    Zamość, 22400

Other trials in Poland

Czechia15 sites

  • Interni A Revmatologicka Ambulance

    Břeclav, 690 02

  • Revmatologie s.r.o.

    Brno, 63800

  • Vesalion s.r.o.

    Ostrava, 702 00

  • Revmatologicka Ambulance

    Ostrava, 70200

  • Lekarna U Svate Anny

    Písek, Czech Republic, 397 01

  • Ortopedicko-traumatologicka ambulance

    Písek, 397 01

  • CCBR Czech Prague, s.r.o

    Prague, 130 00

  • CCR Prague, s.r.o

    Prague, 130 00

  • Revmatologicka ambulance

    Prague, 140 00

  • Thomayerova Nemocnice (TN)

    Prague, 140 00

  • Fakultni Thomayerova nemocnice s poliklinikou

    Prague, 140 59

  • Revmatologicka ambulance

    Prague, 14000

  • EUC Klinika

    Prague, 15000

  • Db Ortopedie s.r.o

    Příbram, 26101

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

    Zlín, 760 01

Other trials in Czechia

France8 sites

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

    Amiens, 80000

  • CHU Amiens Nord

    Amiens, 80054

  • Hopital Edouard Herriot

    Lyon, 69437

  • CHU Nimes Cedex

    Nîmes, 30029

  • Hopital Saint antoine

    Paris, 75012

  • Cochin Hospital-Paris Descartes University

    Paris, 75014

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

    Paris, 75014

  • Hopital Lariboisiere,Hospitalier Universitaire Nord

    Paris, 75475

Other trials in France

Germany8 sites

  • Praxis Dr. med. Stephan Grunert

    Eichstätt, 85072

  • Medizentrum Essen Borbeck

    Essen, 45355

  • HRF Hamburger Rheuma Forschungszentrum

    Hamburg, 20095

  • Ortho-Zentrum Karlsruhe

    Karlsruhe, 76133

  • Velocity Clinical Research Leipzig GmbH

    Leipzig, 04103

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

    Leipzig, 04107

  • Centrum fuer Diagnostik und Gesundheit (CDG)

    München, 80809

  • Praxis-Reinfeld-Mitte

    Reinfeld, 23858

Other trials in Germany

Mexico8 sites

  • Investigacion y Biomedicina de Chihuahua

    Chihuahua City, 31000

  • Clinstile, S.A. de C.V

    Cuauhtémoc, Mexico City, 06700

  • Dr. Miguel Cortes Hernandez MD, Office of

    Cuernavaca, Morelos, 62448

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

    Culiacán, Sinaloa, 80000

  • Centro Integral en Reumatologia, SA de CV

    Guadalajara, Jalisco, 44160

  • Consultorio de Reumatologia

    Gustavo Adolfo Madero, Mexico City, 07760

  • Morales Vargas Centro de Investigacion SC

    León, Guanajuato, 37000

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

    Mexico City, Mexico City, 11850

Other trials in Mexico

Canada7 sites

  • Aggarwal and Associates Limited

    Brampton, Ontario, L6T 0G1

  • Malton Medical Research

    Mississauga, Ontario, L4V 1P1

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

    Sainte-Foy, Quebec, G1V 3M7

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1L 0H8

  • Cook Street Medical Clinic

    Victoria, British Columbia, V8V 4A1

  • Dr. M. B. Jones

    Victoria, British Columbia, V9V 4A1

  • Diex Recherche Victoriaville Inc.

    Victoriaville, Quebec, G6P 6P6

Other trials in Canada

Italy6 sites

  • AOU-Careggi

    Florence, 50134

  • AOU-Careggi

    Florence, 50139

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

    Naples, 80138

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

    Naples, 80138

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089

  • AOU Citta della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Netherlands3 sites

  • PT&R

    Beek, Limburg, 6191 JW

  • Medisch Spectrum Twente (MST) - Enschede Haaksbergerstraat

    Enschede, KZ, 7512 KZ

  • Spaarne Gasthuis (Kennemer Gasthuis)

    Hoofddorp, 2134 TM

Other trials in Netherlands

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of Intra-articular Injections of RTX-GRT7039 in Adult Subjects With Pain Associated With Osteoarthritis of the Knee

A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated injections of RTX-GRT7039 versus placebo in patients who have pain associated with osteoarthritis of the knee despite standard of care.

Read the detailed description

This trial comprises a total observation period of up to 52 weeks.

Conditions
Osteoarthritis
Being tested
RTX-GRT7039, Placebo
Keywords
Knee,, osteoarthritis, pain assessment
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RTX-GRT7039Drug

    RTX-GRT7039 intra-articular injection.

  • PlaceboDrug

    Placebo matching RTX-GRT7039 intra-articular injection.

Study groups in NCT05248386
Study groupRoleWhat they receive
RTX-GRT7039ExperimentalParticipants will receive intra-articular injections of RTX-GRT7039 during the 52-week double-blind treatment period.
Receives: Drug: RTX-GRT7039
PlaceboPlacebo comparatorParticipants will receive intra-articular injections of placebo matching to RTX-GRT7039 during the 52-week double-blind treatment period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Least Squares Mean (Standard Error) [LS-mean (SE)] Change From Baseline in WOMAC Pain Subscale Score at Week 12

    Difference in mean change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score at Week 12 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.

    Measured: Baseline up to Week 12

Secondary outcomes (5)

  1. LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 26

    Difference in mean change from baseline in WOMAC pain subscale score at Week 26 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.

    Measured: From Baseline up to Week 26

  2. LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 52

    Difference in mean change from baseline in WOMAC pain subscale score at Week 52 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.

    Measured: From Baseline up to Week 52

  3. LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 12

    Difference in mean change from baseline in WOMAC physical function subscale score at Week 12 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.

    Measured: From Baseline up to Week 12

  4. LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 26

    Difference in mean change from baseline in WOMAC physical function subscale score at Week 26 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.

    Measured: From Baseline up to Week 26

  5. LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 52

    Difference in mean change from baseline in WOMAC physical function subscale score at Week 26 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.

    Measured: From Baseline up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2022
  2. Study start26 Aug 2022
  3. Primary completion18 Nov 2024
  4. Study completion18 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
469 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05248386
Sponsor's protocol ID
KF7039-01
Other IDs
2021-005029-26, U1111-1268-7314
Status last verified
Feb 2026
First submitted
10 Feb 2022
Last updated
18 Mar 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Information available on the Grünenthal Group Web Site (see URL below for details); according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles.

Publications

  • Berenbaum F, Latourte A, Kivitz A, Ivanavicius S, Buller S, Prasad N, Eibl C, Prevoo M, Conaghan PG. Efficacy and safety of the TRPV1 agonist RTX-GRT7039 in patients with pain associated with knee osteoarthritis: results from a phase 3, randomised, placebo-controlled trial. Osteoarthritis Cartilage. 2026 Oct 22:S1063-4584(26)01092-7. doi: 10.1016/j.joca.2026.10.011. Online ahead of print.

    PubMed 42913877

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RTX-GRT7039 in people with Osteoarthritis, run by Grünenthal GmbH at 103 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in Japan, Poland, Czechia, France, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Least Squares Mean (Standard Error) [LS-mean (SE)] Change From Baseline in WOMAC Pain Subscale Score at Week 12 (time frame: Baseline up to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05248386, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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