Clinical trial NCT05449132: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Knee
Osteoarthritis
Pain assessment
Lead sponsor: Grünenthal GmbH
Sponsor class: INDUSTRY
First posted: 2022-07-08
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
timeFrame: From Baseline up to Week 12
Secondary outcomes:
measure: Change from Baseline in WOMAC Pain Subscale Score
timeFrame: From Baseline up to Week 52
measure: Change from Baseline in WOMAC Physical Function Subscale Score
timeFrame: From Baseline up to Week 52
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From Baseline up to Week 52
measure: Change from Baseline in WOMAC Stiffness Subscale Score
timeFrame: From Baseline up to Week 52
measure: Change from Baseline in WOMAC Total Score
timeFrame: From Baseline up to Week 52
measure: Change from Baseline in WOMAC A1 (Walking Pain) Subscale Score
timeFrame: From Baseline up to Week 52
measure: Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC Pain Subscale Score
timeFrame: From Baseline up to Week 52
measure: Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC A1 (Walking Pain) Subscale Score
timeFrame: From Baseline up to Week 52
measure: Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
timeFrame: From Baseline up to Week 52
measure: Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score
timeFrame: From Baseline up to Week 52
measure: Change From Baseline in EuroQol-5 Dimension Health Questionnaire 5 Levels (EQ-5D-5L) Score
timeFrame: From Baseline up to Week 52
measure: Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores
timeFrame: From Baseline up to Week 52
measure: Number of Participants Reporting Durability of Effect
timeFrame: From Baseline up to Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Glendale
country: United States
facility: Arizona Arthritis and Rheumatology Associates (AARA) P.C
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopaedic Research Center
state: Arizona
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: Cerritos
country: United States
facility: Core Health Care Group
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research, Inc.
state: California
city: Santa Barbara
country: United States
facility: Dr. Hans Richard Barthel, MD Office Of
state: California
city: Thousand Oaks
country: United States
facility: Medvin Clinical Research
state: California
city: Thousand Oaks
country: United States
facility: Westlake Medical Research
state: California
city: Miami
country: United States
facility: Allied Biomedical Research Institute
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research, Corp.
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sarasota
country: United States
facility: Gulfcoast Research Institute
state: Florida
city: Newnan
country: United States
facility: Better Health Clinical Research, Inc.
state: Georgia
city: Newnan
country: United States
facility: Vista Clinical Research
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Boise
country: United States
facility: Injury Care Research
state: Idaho
city: Chicago
country: United States
facility: Chicago Clinical Research Institute Inc.
state: Illinois
city: Hazel Crest
country: United States
facility: Chicago Medical Research, LLC
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Overland Park
country: United States
facility: Neuroscience Research Center, LLC
state: Kansas
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: New Orleans
country: United States
facility: LCMC Health Urgent Care - Lakeview
state: Louisiana
city: Lansing
country: United States
facility: June DO,PC
state: Michigan
city: Troy
country: United States
facility: Oakland Medical Research Center
state: Michigan
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials, LLC
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Charlotte
country: United States
facility: Accellacare Research of Charlotte
state: North Carolina
city: Charlotte
country: United States
facility: Park Road Medical Clinic
state: North Carolina
city: Raleigh
country: United States
facility: Accellacare of Raleigh
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Medical Group
state: North Carolina
city: Winston-Salem
country: United States
facility: Accellacare Research of Winston Salem
state: North Carolina
city: Winston-Salem
country: United States
facility: Gastroenterology Associates of the Piedmont
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center For Clinical Research
state: North Carolina
city: Altoona
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Altoona
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Indiana
country: United States
facility: Antria Inc.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Arthritis Group
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Windber
country: United States
facility: Chan Soon-Shiong Medical Center at Windber
state: Pennsylvania
city: Greenville
country: United States
facility: PCPMG Clinical Research Unit, LLC
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Knoxville
country: United States
facility: Accellacare - Knoxville
state: Tennessee
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center LLC
state: Virginia
city: Amager
country: Denmark
facility: Arthroscopic Center, Copenhagen University Hospital
city: Frederiksberg
country: Denmark
facility: The Parker Institute-Frederiksberg Hospital
city: Alcabideche
country: Portugal
facility: Hospital de Cascais
city: Lisboa
country: Portugal
facility: Hospital Dos Lusiadas Lisboa
city: Porto
country: Portugal
facility: Hospital CUF Porto
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Barcelona
country: Spain
facility: Hospital Sanitas Cima
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Elche
country: Spain
facility: Hospital Universitaro De Elche
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Accellacare Alcobendas
city: Murcia
country: Spain
facility: Hospital Universitario Virgen De La Arrixaca (Huva)
city: Sabadell
country: Spain
facility: Consorci Corporacio Sanitaria Parc Tauli
city: Sabadell
country: Spain
facility: Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
city: Santiago de Compostela
country: Spain
facility: Clinica Gaias
city: Santiago De Compostela
country: Spain
facility: Complexo Hospitalario Universitario De Santiago De Compostela
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario De Santiago De Compostela
city: Sevilla
country: Spain
facility: Hospital Quironsalud Infanta Luisa
city: Corby
country: United Kingdom
facility: Accellacare-Northamptonshire
state: Northamptonshire
city: Oswestry
country: United Kingdom
facility: Robert Jones & Agnes Hunt Orthopaedic Hospital - Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
state: Powys
city: Birmingham
country: United Kingdom
facility: Royal Orthopaedic Hospital - Nhs Foundation Trust
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary - Greater Glasgow Health Board
city: Northwood
country: United Kingdom
facility: Accellacare North London
city: Orpington
country: United Kingdom
facility: Accellacare South London
Study officials:
References: