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

Primary Purpose

Osteoarthritis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RTX-GRT7039
Placebo
Sponsored by
Grünenthal GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Knee,, osteoarthritis, pain assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr. M. B. Jones
  • Aggarwal and Associates Limited
  • Malton Medical Research
  • GRMO (Groupe de Recherche en Rhumatologie et Maladies Osseuses) Inc.
  • Diex Research Sherbrooke Inc.
  • Interni A Revmatologicka Ambulance
  • Revmatologie s.r.o.
  • Revmatologicka Ambulance
  • Ortopedicko-traumatologicka ambulance
  • Revmatologicka ambulance
  • CCR Prague, s.r.o
  • Fakultni Thomayerova nemocnice s poliklinikou
  • EUC Klinika
  • PV-MEDICAL s.r.o. Revmatologicka ambulance
  • CHU Amiens Nord
  • Centre Hospitalier Universitaire d'Amiens-Picardie - Site Sud
  • Hopital Edouard Herriot
  • CHU Nimes Cedex
  • Hopital Saint antoine
  • Hopitaux de Paris (AP-HP) - Groupe Hospitalier Cochin -Assistance Publique
  • Hopital Lariboisiere,Hospitalier Universitaire Nord
  • Praxis Dr. med. Stephan Grunert
  • Medizentrum Essen Borbeck
  • HRF Hamburger Rheuma Forschungszentrum
  • Ortho-Zentrum Karlsruhe
  • Velocity Clinical Research Leipzig GmbH
  • AmBeNet, Practice Dr. Dr. med. Hans-Detlev Stahl
  • Centrum fuer Diagnostik und Gesundheit (CDG)
  • Praxis-Reinfeld-Mitte
  • AOU-Careggi
  • Universita degli Studi della Campania Luigi Vanvitelli - Azienda Ospedaliera Universitaria
  • IRCCS Istituto Clinico Humanitas
  • AOU Citta della Salute e della Scienza di Torino
  • Funabashi Municipal Medical CenterRecruiting
  • Kamagaya General HospitalRecruiting
  • Hamanomachi HospitalRecruiting
  • Souseikai Fukuoka Mirai HospitalRecruiting
  • Kosei General HospitalRecruiting
  • Seiwa-kai medical corporation Hiroshima clinicRecruiting
  • Hakodate Central General HospitalRecruiting
  • Sapporo Maruyama Orthopedic HospitalRecruiting
  • KKR Sapporo Medical CenterRecruiting
  • Sapporo kotoni OrthopediesRecruiting
  • Kinashi Obayashi HospitalRecruiting
  • Yokohoma Rosai HospitalRecruiting
  • KKR Tohoku Kosai HospitalRecruiting
  • Nakajo Orthopedic ClinicRecruiting
  • Marunouchi HospitalRecruiting
  • Otsu City HospitalRecruiting
  • Shimane University HospitalRecruiting
  • Japanese Red Cross Hamamatsu HospitalRecruiting
  • Juntendo University Graduate School of MedicineRecruiting
  • Kitasato University Kitasato Institute HospitalRecruiting
  • Shirahama Hamayu HospitalRecruiting
  • Medical Corporation Teda Ooimachi Orthopaedic Surgery and Surgery ClinicRecruiting
  • Clinstile, S.A. de C.V
  • Consultorio de Reumatologia
  • CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
  • Morales Vargas Centro de Investigacion SC
  • Centro Integral en Reumatologia, SA de CV
  • Dr. Miguel Cortes Hernandez MD, Office of
  • Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C.
  • Investigacion y Biomedicina de Chihuahua
  • Medisch Spectrum Twente (MST) - Enschede Haaksbergerstraat
  • PT&R
  • Spaarne Gasthuis (Kennemer Gasthuis)
  • Reumed Spolka z o.o. Zespol poradni Specjalistycznych Filia Nr 1 Wallenroda
  • Pratia MCM Krakow
  • NZOZ Lecznica MAK-MED S.C.
  • Synexus Poznan Medical Center
  • INTER CLINIC Piotr Adrian Klimiuk
  • Synexus Gdynia
  • Mazowieckie Centrum Badan Klinicznych
  • Synexus Katowice Medical Center
  • Centrum Medyczne Pratia Katowice
  • Malopolskie Centrum Kliniczne
  • Centrum Medyczne Plejady
  • Synexus Polska Sp. z o.o. Oddzial w Lodzi
  • KO-MED Centra Kliniczne Lublin II
  • Synexus Polska Spolka z ograniczona odpowiedzialnoscia Oddzial we Wroclawiu
  • Centrum Medyczne Kuba-Med Zamosc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RTX-GRT7039

Placebo

Arm Description

Participants will receive 2 intra-articular injections of RTX-GRT7039 during the 52-week double-blind treatment period.

Participants will receive 2 intra-articular injections of placebo matching to RTX-GRT7039 during the 52-week double-blind treatment period.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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.
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.
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.
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.
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.
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).
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".
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).
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.

Full Information

First Posted
February 10, 2022
Last Updated
September 25, 2023
Sponsor
Grünenthal GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05248386
Brief Title
Efficacy and Safety of RTX-GRT7039 in Adult Subjects With Knee Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grünenthal GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Knee,, osteoarthritis, pain assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RTX-GRT7039
Arm Type
Experimental
Arm Description
Participants will receive 2 intra-articular injections of RTX-GRT7039 during the 52-week double-blind treatment period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive 2 intra-articular injections of placebo matching to RTX-GRT7039 during the 52-week double-blind treatment period.
Intervention Type
Drug
Intervention Name(s)
RTX-GRT7039
Intervention Description
RTX-GRT7039 intra-articular injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching RTX-GRT7039 intra-articular injection.
Primary Outcome Measure Information:
Title
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Description
The WOMAC pain subscale will be assessed using an 11-point numeric rating scale (NRS), where 0= no pain and 10=worst pain imaginable.
Time Frame
Baseline up to Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline in WOMAC Pain Subscale Score
Description
The WOMAC pain subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable.
Time Frame
From Baseline up to Week 52
Title
Change from Baseline in WOMAC Physical Function Subscale Score
Description
The WOMAC physical function subscale will be assessed using 11-point NRS, where 0= no pain and 10=worst pain imaginable.
Time Frame
From Baseline up to Week 52
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame
From Baseline up to Week 52
Title
Change from Baseline in WOMAC Stiffness Subscale Score
Description
The WOMAC stiffness subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable.
Time Frame
From Baseline up to Week 52
Title
Change from Baseline in WOMAC Total Score
Description
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.
Time Frame
From Baseline up to Week 52
Title
Change from Baseline in WOMAC A1 (Walking Pain) Subscale Score
Description
The WOMAC A1 subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable.
Time Frame
From Baseline up to Week 52
Title
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in WOMAC Pain Subscale Score
Description
The WOMAC pain subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable.
Time Frame
From Baseline up to Week 52
Title
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in WOMAC A1 (Walking Pain) Subscale Score
Description
The WOMAC A1 subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable.
Time Frame
From Baseline up to Week 52
Title
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Description
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).
Time Frame
From Baseline up to Week 52
Title
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score
Description
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".
Time Frame
From Baseline up to Week 52
Title
Change From Baseline in EuroQol-5 Dimension Health Questionnaire 5 Levels (EQ-5D-5L) Score
Description
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).
Time Frame
From Baseline up to Week 52
Title
Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores
Description
The SF-36 domain scores ranged from 0 (worst value) to 100 (best value), with higher scores reflecting better health status.
Time Frame
From Baseline up to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director clinical trials
Phone
+49 241 569
Ext
3223
Email
clinical-trials@grunenthal.com
Facility Information:
Facility Name
Dr. M. B. Jones
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V9V 4A1
Country
Canada
Individual Site Status
Completed
Facility Name
Aggarwal and Associates Limited
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Individual Site Status
Completed
Facility Name
Malton Medical Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4V 1P1
Country
Canada
Individual Site Status
Completed
Facility Name
GRMO (Groupe de Recherche en Rhumatologie et Maladies Osseuses) Inc.
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Individual Site Status
Completed
Facility Name
Diex Research Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Individual Site Status
Completed
Facility Name
Interni A Revmatologicka Ambulance
City
Breclav
ZIP/Postal Code
690 02
Country
Czechia
Individual Site Status
Completed
Facility Name
Revmatologie s.r.o.
City
Brno
ZIP/Postal Code
63800
Country
Czechia
Individual Site Status
Completed
Facility Name
Revmatologicka Ambulance
City
Ostrava
ZIP/Postal Code
70200
Country
Czechia
Individual Site Status
Completed
Facility Name
Ortopedicko-traumatologicka ambulance
City
Pisek
ZIP/Postal Code
397 01
Country
Czechia
Individual Site Status
Completed
Facility Name
Revmatologicka ambulance
City
Prague 4
ZIP/Postal Code
14000
Country
Czechia
Individual Site Status
Completed
Facility Name
CCR Prague, s.r.o
City
Praha 3
ZIP/Postal Code
130 00
Country
Czechia
Individual Site Status
Completed
Facility Name
Fakultni Thomayerova nemocnice s poliklinikou
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Individual Site Status
Completed
Facility Name
EUC Klinika
City
Praha 5
ZIP/Postal Code
15000
Country
Czechia
Individual Site Status
Completed
Facility Name
PV-MEDICAL s.r.o. Revmatologicka ambulance
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Individual Site Status
Completed
Facility Name
CHU Amiens Nord
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Individual Site Status
Completed
Facility Name
Centre Hospitalier Universitaire d'Amiens-Picardie - Site Sud
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Completed
Facility Name
Hopital Edouard Herriot
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Individual Site Status
Completed
Facility Name
CHU Nimes Cedex
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Completed
Facility Name
Hopital Saint antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Completed
Facility Name
Hopitaux de Paris (AP-HP) - Groupe Hospitalier Cochin -Assistance Publique
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Completed
Facility Name
Hopital Lariboisiere,Hospitalier Universitaire Nord
City
Paris
ZIP/Postal Code
75475
Country
France
Individual Site Status
Completed
Facility Name
Praxis Dr. med. Stephan Grunert
City
Eichstätt
ZIP/Postal Code
85072
Country
Germany
Individual Site Status
Completed
Facility Name
Medizentrum Essen Borbeck
City
Essen
ZIP/Postal Code
45355
Country
Germany
Individual Site Status
Completed
Facility Name
HRF Hamburger Rheuma Forschungszentrum
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Individual Site Status
Completed
Facility Name
Ortho-Zentrum Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Individual Site Status
Completed
Facility Name
Velocity Clinical Research Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Completed
Facility Name
AmBeNet, Practice Dr. Dr. med. Hans-Detlev Stahl
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Individual Site Status
Completed
Facility Name
Centrum fuer Diagnostik und Gesundheit (CDG)
City
Muenchen
ZIP/Postal Code
80809
Country
Germany
Individual Site Status
Completed
Facility Name
Praxis-Reinfeld-Mitte
City
Reinfeld
ZIP/Postal Code
23858
Country
Germany
Individual Site Status
Completed
Facility Name
AOU-Careggi
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Completed
Facility Name
Universita degli Studi della Campania Luigi Vanvitelli - Azienda Ospedaliera Universitaria
City
Naples
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Completed
Facility Name
IRCCS Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Completed
Facility Name
AOU Citta della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Completed
Facility Name
Funabashi Municipal Medical Center
City
Funabashi-shi
State/Province
Chiba
ZIP/Postal Code
273-8588
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kamagaya General Hospital
City
Kamagaya
State/Province
Chiba
ZIP/Postal Code
273-0121
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hamanomachi Hospital
City
Fukuoka-shi
State/Province
Fukuoka-ken
ZIP/Postal Code
810-8539
Country
Japan
Individual Site Status
Recruiting
Facility Name
Souseikai Fukuoka Mirai Hospital
City
Fukuoka-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
813-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kosei General Hospital
City
Mihara-shi
State/Province
Hiroshima-ken
ZIP/Postal Code
723-8686
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seiwa-kai medical corporation Hiroshima clinic
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
733-0032
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hakodate Central General Hospital
City
Hakodate
State/Province
Hokkaido
ZIP/Postal Code
040-8585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo Maruyama Orthopedic Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0007
Country
Japan
Individual Site Status
Recruiting
Facility Name
KKR Sapporo Medical Center
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
062-0931
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo kotoni Orthopedies
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
0630814
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kinashi Obayashi Hospital
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
761-8024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohoma Rosai Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
Individual Site Status
Recruiting
Facility Name
KKR Tohoku Kosai Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-0803
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nakajo Orthopedic Clinic
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
983-0862
Country
Japan
Individual Site Status
Recruiting
Facility Name
Marunouchi Hospital
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-0841
Country
Japan
Individual Site Status
Recruiting
Facility Name
Otsu City Hospital
City
Otsu
State/Province
Shiga
ZIP/Postal Code
520-0804
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shimane University Hospital
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Hamamatsu Hospital
City
Hamamatsu-shi
State/Province
Shizuoka-ken
ZIP/Postal Code
434-8533
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo University Graduate School of Medicine
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-0034
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitasato University Kitasato Institute Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shirahama Hamayu Hospital
City
Nishimuro-gun
State/Province
Wakayama-ken
ZIP/Postal Code
649-2211
Country
Japan
Individual Site Status
Recruiting
Facility Name
Medical Corporation Teda Ooimachi Orthopaedic Surgery and Surgery Clinic
City
Tokyo
ZIP/Postal Code
140-0014
Country
Japan
Individual Site Status
Recruiting
Facility Name
Clinstile, S.A. de C.V
City
Cuauhtemoc
State/Province
Ciudad De Mexico
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Completed
Facility Name
Consultorio de Reumatologia
City
Gustavo A. Madero
State/Province
Distrito Federal
ZIP/Postal Code
07760
Country
Mexico
Individual Site Status
Completed
Facility Name
CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
11850
Country
Mexico
Individual Site Status
Completed
Facility Name
Morales Vargas Centro de Investigacion SC
City
León
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Individual Site Status
Completed
Facility Name
Centro Integral en Reumatologia, SA de CV
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Individual Site Status
Completed
Facility Name
Dr. Miguel Cortes Hernandez MD, Office of
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62448
Country
Mexico
Individual Site Status
Completed
Facility Name
Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C.
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80000
Country
Mexico
Individual Site Status
Completed
Facility Name
Investigacion y Biomedicina de Chihuahua
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Completed
Facility Name
Medisch Spectrum Twente (MST) - Enschede Haaksbergerstraat
City
Enschede
State/Province
KZ
ZIP/Postal Code
7512 KZ
Country
Netherlands
Individual Site Status
Completed
Facility Name
PT&R
City
Beek
State/Province
Limburg
ZIP/Postal Code
6191 JW
Country
Netherlands
Individual Site Status
Completed
Facility Name
Spaarne Gasthuis (Kennemer Gasthuis)
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Individual Site Status
Completed
Facility Name
Reumed Spolka z o.o. Zespol poradni Specjalistycznych Filia Nr 1 Wallenroda
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-607
Country
Poland
Individual Site Status
Completed
Facility Name
Pratia MCM Krakow
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-727
Country
Poland
Individual Site Status
Completed
Facility Name
NZOZ Lecznica MAK-MED S.C.
City
Nadarzyn
State/Province
Mazowieckie
ZIP/Postal Code
05-830
Country
Poland
Individual Site Status
Completed
Facility Name
Synexus Poznan Medical Center
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-702
Country
Poland
Individual Site Status
Completed
Facility Name
INTER CLINIC Piotr Adrian Klimiuk
City
Bialystok
ZIP/Postal Code
15-077
Country
Poland
Individual Site Status
Completed
Facility Name
Synexus Gdynia
City
Gdynia
ZIP/Postal Code
81-537
Country
Poland
Individual Site Status
Completed
Facility Name
Mazowieckie Centrum Badan Klinicznych
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Individual Site Status
Completed
Facility Name
Synexus Katowice Medical Center
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Medyczne Pratia Katowice
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Individual Site Status
Completed
Facility Name
Malopolskie Centrum Kliniczne
City
Krakow
ZIP/Postal Code
30-149
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Medyczne Plejady
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Individual Site Status
Completed
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Lodzi
City
Lodz
ZIP/Postal Code
90-127
Country
Poland
Individual Site Status
Completed
Facility Name
KO-MED Centra Kliniczne Lublin II
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Individual Site Status
Completed
Facility Name
Synexus Polska Spolka z ograniczona odpowiedzialnoscia Oddzial we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-381
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Medyczne Kuba-Med Zamosc
City
Zamosc
ZIP/Postal Code
22400
Country
Poland
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.grunenthal.com/en/research-and-development/clinical-trials/data-sharing-clinical-trials

Learn more about this trial

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

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