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Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the Knee

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 in 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

  • Achieve Clinical Research, LLCRecruiting
  • Arizona Arthritis and Rheumatology Associates (AARA) P.CRecruiting
  • Elite Clinical Studies, LLCRecruiting
  • Noble Clinical ResearchRecruiting
  • Tucson Orthopaedic Research CenterRecruiting
  • Orange County Research InstituteRecruiting
  • Core Health Care GroupRecruiting
  • Dream Team Clinical Research
  • Acclaim Clinical Research, Inc.Recruiting
  • Dr. Hans Richard Barthel, MD Office OfRecruiting
  • Medvin Clinical Research
  • Allied Biomedical Research InstituteRecruiting
  • Well Pharma Medical Research, Corp.Recruiting
  • Sensible Healthcare LLCRecruiting
  • Clinical Neuroscience Solutions, Inc. dba CNS HealthcareRecruiting
  • Clinical Neuroscience Solutions, Inc.Recruiting
  • Progressive Medical ResearchRecruiting
  • Gulfcoast Research InstituteRecruiting
  • Horizon Clinical ResearchRecruiting
  • North Georgia Clinical ResearchRecruiting
  • Injury Care ResearchRecruiting
  • Chicago Clinical Research Institute Inc.Recruiting
  • MediSphere Medical Research Center, LLCRecruiting
  • Neuroscience Research Center, LLCRecruiting
  • LCMC Health Urgent Care - LakeviewRecruiting
  • June DO,PC
  • Oakland Medical Research CenterRecruiting
  • Sundance Clinical Research, LLCRecruiting
  • Excel Clinical ResearchRecruiting
  • Las Vegas Clinical Trials, LLCRecruiting
  • Albuquerque Clinical Trials, Inc.Recruiting
  • Drug Trials AmericaRecruiting
  • Upstate Clinical Research AssociatesRecruiting
  • Park Road Medical ClinicRecruiting
  • Accellacare of RaleighRecruiting
  • Accellacare Research of Winston SalemRecruiting
  • The Center For Clinical ResearchRecruiting
  • University Orthopedics CenterRecruiting
  • Altoona Center for Clinical ResearchRecruiting
  • Arthritis GroupRecruiting
  • University Orthopedics CenterRecruiting
  • Chan Soon-Shiong Medical Center at WindberRecruiting
  • PCPMG Clinical Research Unit, LLCRecruiting
  • Coastal Carolina Research CenterRecruiting
  • Health ConceptsRecruiting
  • Accellacare - KnoxvilleRecruiting
  • Wasatch Clinical ResearchRecruiting
  • Charlottesville Medical Research Center LLCRecruiting
  • Arthroscopic Center, Copenhagen University HospitalRecruiting
  • The Parker Institute-Frederiksberg HospitalRecruiting
  • Hospital de CascaisRecruiting
  • Hospital Dos Lusiadas LisboaRecruiting
  • Hospital CUF PortoRecruiting
  • Complejo Hospitalario Universitario A CorunaRecruiting
  • Hospital Sanitas CimaRecruiting
  • Hospital General Universitario de ElcheRecruiting
  • Hospital Universitario Virgen de las NievesRecruiting
  • Hospital Universitario de La PrincesaRecruiting
  • Accellacare AlcobendasRecruiting
  • Hospital Universitario Virgen De La Arrixaca (Huva)Recruiting
  • Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc TauliRecruiting
  • Clinica GaiasRecruiting
  • Hospital Clinico Universitario De Santiago De CompostelaRecruiting
  • Hospital Quironsalud Infanta LuisaRecruiting
  • Accellacare-NorthamptonshireRecruiting
  • Robert Jones & Agnes Hunt Orthopaedic Hospital - Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation TrustRecruiting
  • Glasgow Royal Infirmary - Greater Glasgow Health BoardRecruiting
  • Royal Orthopaedic Hospital - Nhs Foundation TrustRecruiting
  • Accellacare North LondonRecruiting
  • Accellacare South LondonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RTX-GRT7039

Placebo

Arm Description

Participants will receive a single intra-articular injection of RTX-GRT7039 during the 52-week double-blind treatment period.

Participants will receive a single intra-articular injection of placebo matching 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 difficulty and 10=extreme difficulty.
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 stiffness and 10= extreme stiffness.
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=better outcome and 10=worst outcome.
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%, 50% and 70% 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%, 50% and 70% 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 0 (worst imaginable) to 100 (best imaginable).
Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores
The SF-36 domain scores range from 0 (worst value) to 100 (best value), with higher scores reflecting better health status.
Number of Participants Reporting Durability of Effect
Durability of effect is defined as time from an improvement in WOMAC pain subscale to pain recurrence. Pain recurrence is defined as no reduction of >=30% from baseline in the WOMAC Pain subscale score (assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable).

Full Information

First Posted
July 4, 2022
Last Updated
September 25, 2023
Sponsor
Grünenthal GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05449132
Brief Title
Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the Knee
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase III Trial, to Evaluate the Efficacy and Safety of a Single Intra-articular Injection 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
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 single injection 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 a single intra-articular injection of RTX-GRT7039 during the 52-week double-blind treatment period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single intra-articular injection of placebo matching 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
From 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 difficulty and 10=extreme difficulty.
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 stiffness and 10= extreme stiffness.
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=better outcome and 10=worst outcome.
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%, 50% and 70% 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%, 50% and 70% 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 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 range from 0 (worst value) to 100 (best value), with higher scores reflecting better health status.
Time Frame
From Baseline up to Week 52
Title
Number of Participants Reporting Durability of Effect
Description
Durability of effect is defined as time from an improvement in WOMAC pain subscale to pain recurrence. Pain recurrence is defined as no reduction of >=30% from baseline in the WOMAC Pain subscale score (assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable).
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 in 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
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis and Rheumatology Associates (AARA) P.C
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Individual Site Status
Recruiting
Facility Name
Elite Clinical Studies, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Recruiting
Facility Name
Noble Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Recruiting
Facility Name
Tucson Orthopaedic Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Name
Orange County Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Name
Core Health Care Group
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Individual Site Status
Recruiting
Facility Name
Dream Team Clinical Research
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Acclaim Clinical Research, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Hans Richard Barthel, MD Office Of
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93108
Country
United States
Individual Site Status
Recruiting
Facility Name
Medvin Clinical Research
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Completed
Facility Name
Allied Biomedical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Well Pharma Medical Research, Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Sensible Healthcare LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Recruiting
Facility Name
Gulfcoast Research Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Recruiting
Facility Name
Horizon Clinical Research
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Individual Site Status
Recruiting
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Individual Site Status
Recruiting
Facility Name
Injury Care Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Individual Site Status
Recruiting
Facility Name
Chicago Clinical Research Institute Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Individual Site Status
Recruiting
Facility Name
Neuroscience Research Center, LLC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Recruiting
Facility Name
LCMC Health Urgent Care - Lakeview
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Individual Site Status
Recruiting
Facility Name
June DO,PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48911
Country
United States
Individual Site Status
Completed
Facility Name
Oakland Medical Research Center
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Individual Site Status
Recruiting
Facility Name
Sundance Clinical Research, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Recruiting
Facility Name
Las Vegas Clinical Trials, LLC
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Individual Site Status
Recruiting
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Individual Site Status
Recruiting
Facility Name
Upstate Clinical Research Associates
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Individual Site Status
Recruiting
Facility Name
Park Road Medical Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Individual Site Status
Recruiting
Facility Name
Accellacare of Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Individual Site Status
Recruiting
Facility Name
Accellacare Research of Winston Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
The Center For Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
University Orthopedics Center
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Individual Site Status
Recruiting
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152-3303
Country
United States
Individual Site Status
Recruiting
Facility Name
University Orthopedics Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Individual Site Status
Recruiting
Facility Name
Chan Soon-Shiong Medical Center at Windber
City
Windber
State/Province
Pennsylvania
ZIP/Postal Code
15963
Country
United States
Individual Site Status
Recruiting
Facility Name
PCPMG Clinical Research Unit, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Individual Site Status
Recruiting
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Individual Site Status
Recruiting
Facility Name
Accellacare - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Individual Site Status
Recruiting
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Charlottesville Medical Research Center LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthroscopic Center, Copenhagen University Hospital
City
Amager-Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Name
The Parker Institute-Frederiksberg Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Hospital de Cascais
City
Alcabideche
ZIP/Postal Code
2755-009
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Dos Lusiadas Lisboa
City
Lisboa
ZIP/Postal Code
1500-458
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital CUF Porto
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario A Coruna
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Sanitas Cima
City
Barcelona
ZIP/Postal Code
08034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Elche
City
Elche
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Accellacare Alcobendas
City
Madrid
ZIP/Postal Code
28100
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen De La Arrixaca (Huva)
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Gaias
City
Santiago de Compostela
ZIP/Postal Code
15702
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario De Santiago De Compostela
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Quironsalud Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Accellacare-Northamptonshire
City
Corby
State/Province
Northamptonshire
ZIP/Postal Code
NN18 9EZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Robert Jones & Agnes Hunt Orthopaedic Hospital - Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
City
Oswestry
State/Province
Powys
ZIP/Postal Code
SY10 7AG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Glasgow Royal Infirmary - Greater Glasgow Health Board
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Orthopaedic Hospital - Nhs Foundation Trust
City
Northfield Birminham
ZIP/Postal Code
B31 2AP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Accellacare North London
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Accellacare South London
City
Orpington
ZIP/Postal Code
BR5 3QG
Country
United Kingdom
Individual Site Status
Recruiting

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

Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the Knee

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