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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05248386
Other study ID # KF7039-01
Secondary ID 2021-005029-26U1
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date August 26, 2022
Est. completion date February 2024

Study information

Verified date February 2024
Source Grünenthal GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Description:

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 450
Est. completion date February 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RTX-GRT7039
RTX-GRT7039 intra-articular injection.
Placebo
Placebo matching RTX-GRT7039 intra-articular injection.

Locations

Country Name City State
Canada Aggarwal and Associates Limited Brampton Ontario
Canada Malton Medical Research Mississauga Ontario
Canada GRMO (Groupe de Recherche en Rhumatologie et Maladies Osseuses) Inc. Sainte-Foy Quebec
Canada Diex Research Sherbrooke Inc. Sherbrooke Quebec
Canada Cook Street Medical Clinic Victoria British Columbia
Canada Dr. M. B. Jones Victoria British Columbia
Canada Diex Recherche Victoriaville Inc. Victoriaville Quebec
Czechia Interni A Revmatologicka Ambulance Breclav
Czechia Revmatologie s.r.o. Brno
Czechia Revmatologicka Ambulance Ostrava
Czechia Vesalion s.r.o. Ostrava
Czechia Lekarna U Svate Anny Pisek Czech Republic
Czechia Ortopedicko-traumatologicka ambulance Pisek
Czechia Revmatologicka ambulance Prague 4
Czechia CCBR Czech Prague, s.r.o Praha 3
Czechia CCR Prague, s.r.o Praha 3
Czechia Fakultni Thomayerova nemocnice s poliklinikou Praha 4
Czechia Revmatologicka ambulance Praha 4
Czechia Thomayerova Nemocnice (TN) Praha 4
Czechia EUC Klinika Praha 5
Czechia PV-MEDICAL s.r.o. Revmatologicka ambulance Zlin
France Centre Hospitalier Universitaire d'Amiens-Picardie - Site Sud Amiens
France CHU Amiens Nord Amiens Cedex 1
France Hopital Edouard Herriot Lyon
France CHU Nimes Cedex Nîmes
France Cochin Hospital-Paris Descartes University Paris
France Hopital Lariboisiere,Hospitalier Universitaire Nord Paris
France Hopital Saint antoine Paris
France Hopitaux de Paris (AP-HP) - Groupe Hospitalier Cochin -Assistance Publique Paris
Germany Praxis Dr. med. Stephan Grunert Eichstätt
Germany Medizentrum Essen Borbeck Essen
Germany HRF Hamburger Rheuma Forschungszentrum Hamburg
Germany AmBeNet, Practice Dr. Dr. med. Hans-Detlev Stahl Leipzig
Germany Velocity Clinical Research Leipzig GmbH Leipzig
Germany Centrum fuer Diagnostik und Gesundheit (CDG) Muenchen
Germany Praxis-Reinfeld-Mitte Reinfeld
Italy AOU-Careggi Firenze
Italy AOU-Careggi Firenze
Japan KKR Tohoku Kosai Hospital Aoba-ku Sendai-shi
Japan Juntendo University Graduate School of Medicine Bunkyo-ku Tokyo
Japan Juntendo University Hospital Bunkyo-Ku Tokyo
Japan Hamanomachi Hospital Fukuoka-shi Fukuoka-ken
Japan Souseikai Fukuoka Mirai Hospital Fukuoka-shi Fukuoka-Ken
Japan Funabashi Municipal Medical Center Funabashi-shi Chiba
Japan Hakodate Central General Hospital Hakodate Hokkaido
Japan Japanese Red Cross Hamamatsu Hospital Hamamatsu-shi Shizuoka-ken
Japan Seiwa-kai medical corporation Hiroshima clinic Hiroshima-shi Hiroshima
Japan Shimane University Hospital Izumo Shimane
Japan Shimane University Hospital Izumo Shimane
Japan Marunouchi Hospital Matsumoto Nagano
Japan Kosei General Hospital Mihara Hiroshima-ken
Japan Kosei General Hospital Mihara-shi Hiroshima-ken
Japan Kitasato University Kitasato Institute Hospital Minato-ku Tokyo
Japan Social Medical Care Corporation Hosei-kai Marunouchi Hospital Nagano Matsumoto-shi Nagano
Japan Shirahama Hamayu Hospital Nishimuro-gun Wakayama-ken
Japan Otsu City Hospital Otsu Shiga
Japan KKR Sapporo Medical Center Sapporo Hokkaido
Japan Sapporo kotoni Orthopedies Sapporo Hokkaido
Japan Sapporo Maruyama Orthopedic Hospital Sapporo-shi Hokkaido
Japan Nakajo Orthopedic Clinic Sendai Miyagi
Japan KKR Tohoku Kosai Hospital Sendai-shi Miyagi
Japan Kinashi Obayashi Hospital Takamatsu-shi Kagawa
Japan Juntendo University Hospital Tokyo
Japan Medical Corporation Teda Ooimachi Orthopaedic Surgery and Surgery Clinic Tokyo
Japan Yokohoma Rosai Hospital Yokohama Kanagawa
Japan Japan Organization of Occupational Health and Safety Yokohama Rosai Hospital Yokohama-city Kanagawa
Mexico Investigacion y Biomedicina de Chihuahua Chihuahua
Mexico Clinstile, S.A. de C.V Cuauhtemoc Ciudad De Mexico
Mexico Dr. Miguel Cortes Hernandez MD, Office of Cuernavaca Morelos
Mexico Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C. Culiacan Sinaloa
Mexico Centro Integral en Reumatologia, SA de CV Guadalajara Jalisco
Mexico Consultorio de Reumatologia Gustavo A. Madero Distrito Federal
Mexico Morales Vargas Centro de Investigacion SC León Guanajuato
Mexico CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C. Mexico Distrito Federal
Netherlands Medisch Spectrum Twente (MST) - Enschede Haaksbergerstraat Enschede KZ
Netherlands Spaarne Gasthuis (Kennemer Gasthuis) Hoofddorp
Poland Synexus Polska Sp. z o.o. Oddzial w Gdansku Gdansk Pomorskie
Poland Synexus Gdynia Gdynia
Poland Mazowieckie Centrum Badan Klinicznych Grodzisk Mazowiecki
Poland Centrum Medyczne Pratia Katowice Katowice
Poland Synexus Katowice Medical Center Katowice
Poland Malopolskie Centrum Kliniczne Krakow
Poland Pratia MCM Krakow Krakow Malopolskie
Poland St Centrum Medyczne Plejady Krakow
Poland Synexus Polska Sp. z o.o. Oddzial w Lodzi Lodz
Poland KO-MED Centra Kliniczne Lublin II Lublin
Poland Reumed Spolka z o.o. Zespol poradni Specjalistycznych Filia Nr 1 Wallenroda Lublin Lubelskie
Poland Makmed Nzoz Nadarzyn Mazowieckie
Poland NZOZ Lecznica MAK-MED S.C. Nadarzyn Mazowieckie
Poland Synexus Poznan Medical Center Poznan Wielkopolskie
Poland Synexus Polska Spolka z ograniczona odpowiedzialnoscia Oddzial we Wroclawiu Wroclaw
Poland Centrum Medyczne Kuba-Med Zamosc Zamosc
Poland KO-MED Centra Kliniczne Lublin II Zamosc Lubelskie

Sponsors (1)

Lead Sponsor Collaborator
Grünenthal GmbH

Countries where clinical trial is conducted

Canada,  Czechia,  France,  Germany,  Italy,  Japan,  Mexico,  Netherlands,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score The WOMAC pain subscale will be assessed using an 11-point numeric rating scale (NRS), where 0= no pain and 10=worst pain imaginable. Baseline up to Week 12
Secondary Change from Baseline in WOMAC Pain Subscale Score The WOMAC pain subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable. From Baseline up to Week 52
Secondary Change from Baseline in WOMAC Physical Function Subscale Score The WOMAC physical function subscale will be assessed using 11-point NRS, where 0= no pain and 10=worst pain imaginable. From Baseline up to Week 52
Secondary Number of Participants With Treatment Emergent Adverse Events (TEAEs) From Baseline up to Week 52
Secondary Change from Baseline in WOMAC Stiffness Subscale Score The WOMAC stiffness subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable. From Baseline up to Week 52
Secondary Change from Baseline in WOMAC Total Score The WOMAC total score will be calculated as the sum of pain subscale score, stiffness subscale score and physical function subscale score. It will be calculated by averaging all of the scores available for the questions and assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable. From Baseline up to Week 52
Secondary Change from Baseline in WOMAC A1 (Walking Pain) Subscale Score The WOMAC A1 subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable. From Baseline up to Week 52
Secondary Percentage of Participants With at Least 30% and 50% Reduction From Baseline in WOMAC Pain Subscale Score The WOMAC pain subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable. From Baseline up to Week 52
Secondary Percentage of Participants With at Least 30% and 50% Reduction From Baseline in WOMAC A1 (Walking Pain) Subscale Score The WOMAC A1 subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable. From Baseline up to Week 52
Secondary Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response OMERACT-OARSI response: A high improvement of >=50% (percentage change) and >=2 (absolute change) in either the WOMAC pain subscale score or WOMAC physical function subscale score, OR An improvement in at least 2 of the following 3:
Improvement of >=20% (percentage change) and >=1 (absolute change) in the WOMAC pain subscale score.
Improvement of >=20% (percentage change) and >=1 (absolute change) in the WOMAC physical function subscale score.
Improvement of >=20% (percentage change) and >=10 (absolute change) in Patient Global Assessment (PGA) of osteoarthritis. Absolute values will be normalized to the 0 (no pain) to 100 scale (higher pain/difficulty).
From Baseline up to Week 52
Secondary Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score The 7-point PGIC is a complementary assessment of analgesic efficacy on a 7-point scale where 1 = "Very much improved" and 7 = "Very much worse". From Baseline up to Week 52
Secondary Change From Baseline in EuroQol-5 Dimension Health Questionnaire 5 Levels (EQ-5D-5L) Score EQ-5D consists of EQ-5D descriptive system (Index score) and EQ visual analogue scale (VAS). EQ-5D-5L Index Score ranges from 0 to 1, with 0 representing death and 1.0 representing perfect health. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that range from where 0 (worst imaginable) to 100 (best imaginable). From Baseline up to Week 52
Secondary Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores The SF-36 domain scores ranged from 0 (worst value) to 100 (best value), with higher scores reflecting better health status. From Baseline up to Week 52
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