Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee
NCT ID: NCT05377489
Last Updated: 2025-11-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
714 participants
INTERVENTIONAL
2022-09-15
2025-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RTX-GRT7039
Participants will receive injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with highest pain intensity), or each of both knees up to Week 52.
RTX-GRT7039
RTX-GRT7039 monoarticular injections or bilateral intra-articular injections.
Interventions
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RTX-GRT7039
RTX-GRT7039 monoarticular injections or bilateral intra-articular injections.
Eligibility Criteria
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Inclusion Criteria
* 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 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 at the index knee from any cause other than osteoarthritis, 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 Type II,pathologic fracture, primary or metastatic tumor, or joint infection in the index knee.
* 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 radiograph 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 safety assessments, or any other reason which 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.
18 Years
ALL
No
Sponsors
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Grünenthal GmbH
INDUSTRY
Responsible Party
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Locations
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Arizona Arthritis and Rheumatology Associates (AARA) P.C
Glendale, Arizona, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Orange County Research Institute
Anaheim, California, United States
Acclaim Clinical Research, Inc.
San Diego, California, United States
Westlake Medical Research
Thousand Oaks, California, United States
Progressive Medical Research
Port Orange, Florida, United States
Gulfcoast Research Institute
Sarasota, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
Injury Care Research
Boise, Idaho, United States
Chicago Clinical Research Institute Inc.
Chicago, Illinois, United States
OrthoIndy, Inc.
Greenwood, Indiana, United States
University Of Kansas Medical Center
Kansas City, Kansas, United States
Neuroscience Research Center, LLC
Overland Park, Kansas, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Oakland Medical Research Center
Troy, Michigan, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, United States
Drug Trials America
Hartsdale, New York, United States
M3-Emerging Medical Research, LLC
Durham, North Carolina, United States
M3-Emerging Medical Research, LLC
Raleigh, North Carolina, United States
University Orthopedics Center
State College, Pennsylvania, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Accellacare-Knoxville
Knoxville, Tennessee, United States
Tekton Research, Inc.
San Antonio, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
UMHAT Eurohospital Plovdiv OOD
Plovdiv, , Bulgaria
Medical Centre Artmed
Plovdiv, , Bulgaria
MHAT Kaspela EOOD
Plovdiv, , Bulgaria
UMHAT Pulmed
Plovdiv, , Bulgaria
University Multiprofile Hospital For Active Treatment Pulmed OOD
Plovdiv, , Bulgaria
Medical Centre N. I. Pirogov EOOD
Sofia, , Bulgaria
MHAT St Iv. Rilski
Sofia, , Bulgaria
UMBAL Sveti Ivan Rilski EAD
Sofia, , Bulgaria
Synexus Medical Center Sofia
Sofia, , Bulgaria
Multi-Profile District Hospital for Active Treatment Dr. Stefan Cherkezov
Veliko Tarnovo, , Bulgaria
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Medical Corporation Kouhoukai Takagi Hospital
Okawa-shi, Fukuoka, Japan
Hakodate Central General Hospital
Hakodate, Hokkaido, Japan
Saiseikai Kanagawaken Hospital
Yokohama, Kanagawa, Japan
Otakibashi Orthopedic Clinic
Shinjuku-ku, Tokyo, Japan
Saitama Medical Center
Saitama, , Japan
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Medyczne 4M Plus
Krakow, Malopolska, Poland
ETG Warszawa
Warsaw, Masovian Voivodeship, Poland
ClinicMed Badurski I Wspolnicy Spolka Jawna
Bialystok, , Poland
ClinicMed Daniluk, Nowak Spolka komandytowa
Bialystok, , Poland
Zaklad Opieki Zdrowotnej w Boleslawcu
Bolesławiec, , Poland
Centrum Kliniczno
Elblag, , Poland
NZOZ Medi Spatz
Gliwice, , Poland
PZU Zdrowie S.A. Oddzia¿ Centrum Medyczne Artimed w Kielcach
Kielce, , Poland
Centrum Medyczne Semper fortis
Krakow, , Poland
Centermed Krakow Sp. z o.o.
Krakow, , Poland
Nzoz Centermed Krakow, Szpital I Przychodnia
Krakow, , Poland
ETYKA Osrodek Badan Klinicznych
Olsztyn, , Poland
Medyczne Centrum Hetmanska Indywidualna Specjalistyczna Praktyka Lekarska Dr Hab Piotr Leszczynski
Poznan, , Poland
Medyczne Centrum Hetmanska
Poznan, , Poland
RCMed Oddzial Sochaczew
Sochaczew, , Poland
RCMed Piotr Opadczuk
Sochaczew, , Poland
Lubelskie Centrum Diagnostyczne
Świdnik, , Poland
ETG Warszawa
Warsaw, , Poland
Europejskie Centrum leczenia Chorob Cywilizacyjnych
Warsaw, , Poland
ETG Warszawa
Warsaw, , Poland
Wojewodzki Szpital Zespolony W Kielcach
Kielce, Świętokrzyskie Voivodeship, Poland
Spitalul Judetean Caracal
Caracal, Olt, Romania
SC Medicali's SRL
Timișoara, Timiș County, Romania
SC Medaudio-Optica SRL
Râmnicu Vâlcea, Vâlcea County, Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
Brasov, , Romania
SC Centrul Medical Sana SRL
Bucharest, , Romania
Spitalul Clinic Sf. Maria
Bucharest, , Romania
Spital Clinic Dr I Cantacuzino
Bucharest, , Romania
SC Policlinica CCBR SRL
Bucharest, , Romania
Sf. Maria Hospital
Bucharest, , Romania
Tread Research
Parow, Cape Town, South Africa
Tygerberg hospital
Parow, Cape Town, South Africa
Josha Research
Bloemfontein, Free State, South Africa
Welkom Clinical Trial Centre
Welkom, Free State, South Africa
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Pretoria, Gauteng, South Africa
Roodepoort Medicross Clinical Research Centre
Roodepoort, Gauteng, South Africa
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Sandton, Gauteng, South Africa
Clinresco Centres (Pty) Ltd.
Kempton Park, Johannesburg, South Africa
Synapta Clinical Research Center
Durban, KwaZulu-Natal, South Africa
Dr Zubar Fazal Ahmed Vawda MD
Durban, KwaZulu-Natal, South Africa
Precise Clinical Solutions
Durban, KwaZulu-Natal, South Africa
Aliwal Shoal Medical Centre
eMkhomazi, KwaZulu-Natal, South Africa
Medicross Langeberg Medical & Dental Centre
Kraaifontein, Western Cape, South Africa
Medicross Langeberg Medical & Dental Centre
Kraaifontein, Western Cape, South Africa
Arthritis Clinical Research Centre
Cape Town, , South Africa
Accellacare Yorkshire
Shipley, Yorkshire, United Kingdom
Accellacare Warwickshire
Coventry, , United Kingdom
Chapel Allerton Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2021-005046-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1268-7230
Identifier Type: OTHER
Identifier Source: secondary_id
2024-515709-24-00
Identifier Type: CTIS
Identifier Source: secondary_id
KF7039-03
Identifier Type: -
Identifier Source: org_study_id
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