Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the Knee
NCT ID: NCT05449132
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
450 participants
INTERVENTIONAL
2022-09-26
2024-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RTX-GRT7039
Participants will receive a intra-articular injection of RTX-GRT7039 during the 52-week double-blind treatment period.
RTX-GRT7039
RTX-GRT7039 intra-articular injection.
Placebo
Participants will receive a intra-articular injection of placebo matching RTX-GRT7039 during the 52-week double-blind treatment period.
Placebo
Placebo matching RTX-GRT7039 intra-articular injection.
Interventions
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RTX-GRT7039
RTX-GRT7039 intra-articular injection.
Placebo
Placebo matching RTX-GRT7039 intra-articular injection.
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 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.
18 Years
ALL
No
Sponsors
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Grünenthal GmbH
INDUSTRY
Responsible Party
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Locations
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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Arizona Arthritis and Rheumatology Associates (AARA) P.C
Glendale, Arizona, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Tucson Orthopaedic Research Center
Tucson, Arizona, United States
Orange County Research Institute
Anaheim, California, United States
Core Health Care Group
Cerritos, California, United States
Acclaim Clinical Research, Inc.
San Diego, California, United States
Dr. Hans Richard Barthel, MD Office Of
Santa Barbara, California, United States
Medvin Clinical Research
Thousand Oaks, California, United States
Westlake Medical Research
Thousand Oaks, California, United States
Allied Biomedical Research Institute
Miami, Florida, United States
Well Pharma Medical Research, Corp.
Miami, Florida, United States
Sensible Healthcare LLC
Ocoee, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Orlando, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Gulfcoast Research Institute
Sarasota, Florida, United States
Better Health Clinical Research, Inc.
Newnan, Georgia, United States
Vista Clinical Research
Newnan, Georgia, 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
Chicago Medical Research, LLC
Hazel Crest, Illinois, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Neuroscience Research Center, LLC
Overland Park, Kansas, United States
DelRicht Research
New Orleans, Louisiana, United States
LCMC Health Urgent Care - Lakeview
New Orleans, Louisiana, United States
June DO,PC
Lansing, Michigan, United States
Oakland Medical Research Center
Troy, Michigan, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Drug Trials America
Hartsdale, New York, United States
Upstate Clinical Research Associates
Williamsville, New York, United States
Accellacare Research of Charlotte
Charlotte, North Carolina, United States
Park Road Medical Clinic
Charlotte, North Carolina, United States
Accellacare of Raleigh
Raleigh, North Carolina, United States
Raleigh Medical Group
Raleigh, North Carolina, United States
Accellacare Research of Winston Salem
Winston-Salem, North Carolina, United States
Gastroenterology Associates of the Piedmont
Winston-Salem, North Carolina, United States
The Center For Clinical Research
Winston-Salem, North Carolina, United States
University Orthopedics Center
Altoona, Pennsylvania, United States
University Orthopedics Center
Altoona, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Antria Inc.
Indiana, Pennsylvania, United States
Arthritis Group
Philadelphia, Pennsylvania, United States
University Orthopedics Center
State College, Pennsylvania, United States
Chan Soon-Shiong Medical Center at Windber
Windber, Pennsylvania, United States
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
Accellacare - Knoxville
Knoxville, Tennessee, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Charlottesville Medical Research Center LLC
Charlottesville, Virginia, United States
Arthroscopic Center, Copenhagen University Hospital
Amager, , Denmark
The Parker Institute-Frederiksberg Hospital
Frederiksberg, , Denmark
Hospital de Cascais
Alcabideche, , Portugal
Hospital Dos Lusiadas Lisboa
Lisbon, , Portugal
Hospital CUF Porto
Porto, , Portugal
Complejo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital Sanitas Cima
Barcelona, , Spain
Hospital General Universitario de Elche
Elche, , Spain
Hospital Universitaro De Elche
Elche, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Accellacare Alcobendas
Madrid, , Spain
Hospital Universitario Virgen De La Arrixaca (Huva)
Murcia, , Spain
Consorci Corporacio Sanitaria Parc Tauli
Sabadell, , Spain
Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
Sabadell, , Spain
Clinica Gaias
Santiago de Compostela, , Spain
Complexo Hospitalario Universitario De Santiago De Compostela
Santiago de Compostela, , Spain
Hospital Clinico Universitario De Santiago De Compostela
Santiago de Compostela, , Spain
Hospital Quironsalud Infanta Luisa
Seville, , Spain
Accellacare-Northamptonshire
Corby, Northamptonshire, United Kingdom
Robert Jones & Agnes Hunt Orthopaedic Hospital - Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Powys, United Kingdom
Royal Orthopaedic Hospital - Nhs Foundation Trust
Birmingham, , United Kingdom
Glasgow Royal Infirmary - Greater Glasgow Health Board
Glasgow, , United Kingdom
Accellacare North London
Northwood, , United Kingdom
Accellacare South London
Orpington, , United Kingdom
Countries
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Other Identifiers
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2021-005020-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1268-7267
Identifier Type: OTHER
Identifier Source: secondary_id
KF7039-02
Identifier Type: -
Identifier Source: org_study_id
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