Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee

Last updated: March 20, 2025
Sponsor: Grünenthal GmbH
Overall Status: Active - Not Recruiting

Phase

3

Condition

Osteoarthritis

Treatment

RTX-GRT7039

Clinical Study ID

NCT05377489
KF7039-03
2024-515709-24-00
2021-005046-15
U1111-1268-7230
  • Ages > 18
  • All Genders

Study Summary

An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in patients who have pain associated with osteoarthritis of the knee despite standard of care.

Eligibility Criteria

Inclusion

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 AmericanCollege of Rheumatology criteria and functional capacity class of I to III.

  • There is a documented history indicating that participant has insufficient painrelief with previous Standard of Care.

Exclusion

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 orarthroscopic) to the index knee within 12 months of Screening.

  • The participant has periarticular pain at the index knee from any cause other thanosteoarthritis, including referred pain, bursitis, tendonitis.

  • The participant has clinical hip osteoarthritis on the side of the index knee.

  • The participant has a history of osteonecrosis, subchondral insufficiency fracture,atrophic osteoarthritis, rapidly progressing osteoarthritis (RPOA) Type I or TypeII,pathologic fracture, primary or metastatic tumor, or joint infection in the indexknee.

  • The participant has significant malalignment of anatomical axis (medial angle formedby the femur and tibia) of the target knee (varus >10°, valgus >10°) by radiographas assessed by independent Central Readers at Screening Visit.

  • The participant has other conditions that could affect trial endpoint assessments ofthe index knee.

  • The participant has current clinically significant disease(s) or condition(s) thatmay affect safety assessments, or any other reason which may preclude theparticipant's participation for the full duration of the trial.

  • The participant has a history of hypersensitivity to resiniferatoxin (RTX) or anysimilar component (capsaicin, chili peppers).

  • The participant is currently participating or was participating in anotherinvestigational drug trial within 3 months prior to the Screening Visit.

  • The participant is an employee of the investigator or trial site, with directinvolvement in the proposed trial or other trials under the direction of thatinvestigator or trial site or is a family member of the employees or theinvestigator.

The non-index knee is not eligible for treatment in the trial, if any of the knee-related exclusion criteria applies to the non-index knee.

Study Design

Total Participants: 930
Treatment Group(s): 1
Primary Treatment: RTX-GRT7039
Phase: 3
Study Start date:
September 15, 2022
Estimated Completion Date:
May 16, 2025

Study Description

This trial comprises a total observation period of up to 78 weeks.

Connect with a study center

  • MHAT Kaspela EOOD

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Medical Centre Artmed

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • UMHAT Eurohospital Plovdiv OOD

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • UMHAT Pulmed

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital For Active Treatment Pulmed OOD

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • MHAT St Iv. Rilski

    Sofia, 1612
    Bulgaria

    Site Not Available

  • Medical Centre N. I. Pirogov EOOD

    Sofia, 1000
    Bulgaria

    Site Not Available

  • Synexus Medical Center Sofia

    Sofia, 1784
    Bulgaria

    Site Not Available

  • UMBAL Sveti Ivan Rilski EAD

    Sofia, 1612
    Bulgaria

    Site Not Available

  • Multi-Profile District Hospital for Active Treatment Dr. Stefan Cherkezov

    Weliko Tarnowo, 5000
    Bulgaria

    Site Not Available

  • Centro de Investigación Médico Asistencial S.A.S - CIMEDICAL S.A.S

    Barranquilla, Atlántico 080020
    Colombia

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka-shi, Fukuoka 8140180
    Japan

    Site Not Available

  • Kitakyushu General Hospital

    Kitakyushu-city, Fukuoka 802-8517
    Japan

    Site Not Available

  • Medical Corporation Kouhoukai Takagi Hospital

    Okawa-shi, Fukuoka 831-0016
    Japan

    Site Not Available

  • Hakodate Central General Hospital

    Hakodate, Hokkaido 040-8585
    Japan

    Site Not Available

  • Saiseikai Kanagawaken Hospital

    Yokohama-shi, Kanagawa 221-0821
    Japan

    Site Not Available

  • Otakibashi Orthopedic Clinic

    Shinjuku-ku, Tokyo 169-0073
    Japan

    Site Not Available

  • Saitama Medical Center

    Saitama, 350-8550
    Japan

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, Dolnoslaskie 50-556
    Poland

    Site Not Available

  • Centrum Medyczne 4M Plus

    Krakow, Malopolska 31141
    Poland

    Site Not Available

  • Centrum Medyczne Novumed

    Jablonna, Mazowieckie 05-110
    Poland

    Site Not Available

  • ETG Warszawa

    Warsaw, Mazowieckie 02-777
    Poland

    Site Not Available

  • Wojewodzki Szpital Zespolony W Kielcach

    Kielce, Świętokrzyskie 25-736
    Poland

    Site Not Available

  • ClinicMed Badurski I Wspolnicy Spolka Jawna

    Bialystok, 15-879
    Poland

    Site Not Available

  • ClinicMed Daniluk, Nowak Spolka

    Bialystok, 15-879
    Poland

    Active - Recruiting

  • ClinicMed Daniluk, Nowak Spolka Jawna

    Bialystok, 15-879
    Poland

    Active - Recruiting

  • ClinicMed Daniluk, Nowak Spolka komandytowa

    Bialystok, 15-879
    Poland

    Site Not Available

  • Zaklad Opieki Zdrowotnej w Boleslawcu

    Boleslawiec, 59-700
    Poland

    Site Not Available

  • Centrum Kliniczno

    Elblag, 82-300
    Poland

    Site Not Available

  • NZOZ Medi Spatz

    Gliwice, 44-100
    Poland

    Site Not Available

  • Medyczne Centrum Hetmanska

    Hetmanska, 62064
    Poland

    Site Not Available

  • PZU Zdrowie S.A. Oddzia¿ Centrum Medyczne Artimed w Kielcach

    Kielce, 25-017
    Poland

    Site Not Available

  • Centermed Krakow Sp. z o.o.

    Krakow, 31-530
    Poland

    Site Not Available

  • Centrum Medyczne 4M

    Krakow, 31-141
    Poland

    Active - Recruiting

  • Centrum Medyczne Semper fortis

    Krakow, 31-141
    Poland

    Site Not Available

  • Nzoz Centermed Krakow, Szpital I Przychodnia

    Krakow, 31-530
    Poland

    Site Not Available

  • ETYKA Osrodek Badan Klinicznych

    Olsztyn, 10-117
    Poland

    Site Not Available

  • Medyczne Centrum Hetmanska

    Poznań, 60-218
    Poland

    Site Not Available

  • Medyczne Centrum Hetmanska Indywidualna Specjalistyczna Praktyka Lekarska Dr Hab Piotr Leszczynski

    Poznań, 60-218
    Poland

    Site Not Available

  • RCMed Oddzial Sochaczew

    Sochaczew, 96-500
    Poland

    Site Not Available

  • RCMed Piotr Opadczuk

    Sochaczew, 96-500
    Poland

    Site Not Available

  • Lubelskie Centrum Diagnostyczne

    Swidnik, 21040
    Poland

    Site Not Available

  • ETG Warszawa

    Warszawa, 02-793
    Poland

    Site Not Available

  • Europejskie Centrum leczenia Chorob Cywilizacyjnych

    Warszawa, 02-777
    Poland

    Site Not Available

  • Spitalul Judetean Caracal

    Caracal, Olt 235200
    Romania

    Site Not Available

  • SC Medicali's SRL

    Timişoara, Timis 300362
    Romania

    Site Not Available

  • SC Medaudio-Optica SRL

    Râmnicu Vâlcea, Valcea 240762
    Romania

    Site Not Available

  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL

    Brasov, 500283
    Romania

    Site Not Available

  • SC Policlinica CCBR SRL

    Bucharest, 030463
    Romania

    Site Not Available

  • Sf. Maria Hospital

    Bucharest, 11172
    Romania

    Site Not Available

  • Spital Clinic Dr I Cantacuzino

    Bucharest, 020475
    Romania

    Site Not Available

  • SC Centrul Medical Sana SRL

    Bucuresti, 011025
    Romania

    Site Not Available

  • Spitalul Clinic Sf. Maria

    Bucuresti, 011172
    Romania

    Site Not Available

  • Tread Research

    Parow, Cape Town 7500
    South Africa

    Site Not Available

  • Tread Research-Tygerberg Hospital

    Parow, Cape Town 7500
    South Africa

    Site Not Available

  • Tygerberg hospital

    Parow, Cape Town 7500
    South Africa

    Site Not Available

  • JOSHA Research

    Bloemfontein, Free State 9301
    South Africa

    Active - Recruiting

  • Josha Research

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Welkom Clinical Trial Centre

    Welkom, Free State 9460
    South Africa

    Site Not Available

  • Worthwhile Clinical Trials

    Benoni, Gauteng
    South Africa

    Site Not Available

  • Midrand Medical Centre

    Halfway House, Gauteng 1685
    South Africa

    Site Not Available

  • Lakeview Hospital

    Johannesburg, Gauteng 1500
    South Africa

    Site Not Available

  • Global Clinical Trials

    Pretoria, Gauteng 0001
    South Africa

    Site Not Available

  • University of Pretoria

    Pretoria, Gauteng 0002
    South Africa

    Site Not Available

  • Roodepoort Medicross Clinical Research Centre

    Roodepoort, Gauteng 1724
    South Africa

    Site Not Available

  • Sandton Medical Research (Newtown CRC)

    Sandton, Gauteng 2196
    South Africa

    Site Not Available

  • Clinresco Centres (Pty) Ltd.

    Kempton Park, Johannesburg 1619
    South Africa

    Site Not Available

  • Dr Zubar Fazal Ahmed Vawda MD

    Durban, Kwa Zulu Natal 4091
    South Africa

    Site Not Available

  • Dr. ZFA Vawda MD

    Durban, Kwa Zulu Natal 4091
    South Africa

    Site Not Available

  • Precise Clinical Solutions

    Durban, Kwa-Zulu Natal 4092
    South Africa

    Site Not Available

  • Synapta Clinical Research Center

    Durban, Kwa-Zulu Natal 4001
    South Africa

    Site Not Available

  • Aliwal Shoal Medical Centre

    Umkomaas, Kwa-Zulu Natal 4170
    South Africa

    Site Not Available

  • Langeberg Clinical Trials

    Kraaifontein, Western Cape 7570
    South Africa

    Active - Recruiting

  • Medicross Langeberg Medical & Dental Centre

    Kraaifontein, Western Cape 7570
    South Africa

    Site Not Available

  • Arthritis Clinical Research Centre

    Cape Town, 7405
    South Africa

    Site Not Available

  • Accellacare - (MeDiNova Limited)

    Shipley, Yorkshire BD18 3SA
    United Kingdom

    Active - Recruiting

  • Accellacare Yorkshire

    Shipley, Yorkshire BD18 3SA
    United Kingdom

    Site Not Available

  • Accellacare Warwickshire

    Coventry, CV3 4FJ
    United Kingdom

    Site Not Available

  • Accellacare Warwickshire Quality Research Site

    Coventry, CV3 4FJ
    United Kingdom

    Active - Recruiting

  • Chapel Allerton Hospital - Leeds Teaching Hospitals NHS Trust

    Leeds, LS7 4SA
    United Kingdom

    Site Not Available

  • Arizona Arthritis and Rheumatology Associates (AARA) P.C

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Elite Clinical Studies, LLC

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Orange County Research Institute

    Anaheim, California 92801
    United States

    Site Not Available

  • Acclaim Clinical Research, Inc.

    San Diego, California 92120
    United States

    Site Not Available

  • Westlake Medical Research

    Thousand Oaks, California 91360
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Gulfcoast Research Institute

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Palm Beach Research Center

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Site Not Available

  • Injury Care Research

    Boise, Idaho 83713
    United States

    Site Not Available

  • Chicago Clinical Research Institute Inc.

    Chicago, Illinois 60607
    United States

    Site Not Available

  • OrthoIndy, Inc.

    Greenwood, Indiana 46143
    United States

    Site Not Available

  • University Of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Neuroscience Research Center, LLC

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Oakland Medical Research Center

    Troy, Michigan 48085
    United States

    Site Not Available

  • Excel Clinical Research

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Las Vegas Clinical Trials, LLC

    North Las Vegas, Nevada 89030
    United States

    Site Not Available

  • Drug Trials America

    Hartsdale, New York 10530
    United States

    Site Not Available

  • M3-Emerging Medical Research, LLC

    Durham, North Carolina 27704
    United States

    Site Not Available

  • M3-Emerging Medical Research, LLC

    Raleigh, North Carolina 27704
    United States

    Site Not Available

  • University Orthopedics Center

    State College, Pennsylvania 16801
    United States

    Site Not Available

  • Coastal Carolina Research Center

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Accellacare, US Inc., d/b/a Accellacare of Knoxville

    Knoxville, Tennessee 37912
    United States

    Site Not Available

  • Accellacare-Knoxville

    Knoxville, Tennessee 37912
    United States

    Site Not Available

  • Tekton Research, Inc.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Wasatch Clinical Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

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