Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the Knee
A legfontosabb adatok
- Hol
- Albuquerque, Altoona, Anaheim, Birmingham, Boise, Cerritos, Charlotte, Charlottesville, Chicago, Duncansville, Evansville, Glendale, Greenville, Hartsdale, Hazel Crest, Indiana, Knoxville, Lansing, Las Vegas, Miami, New Orleans, Newnan, North Charleston, North Las Vegas, Ocoee, Orlando, Overland Park, Philadelphia, Phoenix, Port Orange, Raleigh, Rapid City, Salt Lake City, San Diego, Santa Barbara, Sarasota, St Louis, State College, Thousand Oaks, Troy, Tucson, Williamsville, Windber, Winston-Salem és Woodstock (Egyesült Államok)Mind a 55 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- Albuquerque Clinical Trials, Inc.Albuquerque, Egyesült ÁllamokNo longer taking part
- University Orthopedics CenterAltoona, Egyesült ÁllamokNo longer taking part
- Orange County Research InstituteAnaheim, Egyesült ÁllamokNo longer taking part
- Achieve Clinical Research, LLCBirmingham, Egyesült ÁllamokNo longer taking part
- Injury Care ResearchBoise, Egyesült ÁllamokNo longer taking part
- Core Health Care GroupCerritos, Egyesült ÁllamokNo longer taking part
- Accellacare Research of CharlotteCharlotte, Egyesült ÁllamokNo longer taking part
- Park Road Medical ClinicCharlotte, Egyesült ÁllamokNo longer taking part
- Charlottesville Medical Research Center, LLCCharlottesville, Egyesült ÁllamokNo longer taking part
- Chicago Clinical Research Institute INCChicago, Egyesült ÁllamokNo longer taking part
- Altoona Center For Clinical ResearchDuncansville, Egyesült ÁllamokNo longer taking part
- MediSphere Medical Research Center, LLCEvansville, Egyesült ÁllamokNo longer taking part
- Arizona Arthritis and Rheumatology Associates (AARA) P.CGlendale, Egyesült ÁllamokNo longer taking part
- PCPMG Clinical Research Unit, LLCGreenville, Egyesült ÁllamokNo longer taking part
- Drug Trials AmericaHartsdale, Egyesült ÁllamokNo longer taking part
- Chicago Medical Research LLCHazel Crest, Egyesült ÁllamokNo longer taking part
- Antria Inc.Indiana, Egyesült ÁllamokNo longer taking part
- Accellacare - KnoxvilleKnoxville, Egyesült ÁllamokNo longer taking part
- June DO, PCLansing, Egyesült ÁllamokNo longer taking part
- Excel Clinical ResearchLas Vegas, Egyesült ÁllamokNo longer taking part
- Allied Biomedical Research InstituteMiami, Egyesült ÁllamokNo longer taking part
- Well Pharma Medical Research Corp.Miami, Egyesült ÁllamokNo longer taking part
- Delricht ResearchNew Orleans, Egyesült ÁllamokNo longer taking part
- LCMC Health Urgent Care - LakeviewNew Orleans, Egyesült ÁllamokNo longer taking part
- Better Health Clinical Research, Inc.Newnan, Egyesült ÁllamokNo longer taking part
- Vista Clinical ResearchNewnan, Egyesült ÁllamokNo longer taking part
- Coastal Carolina Research CenterNorth Charleston, Egyesült ÁllamokNo longer taking part
- Las Vegas Clinical Trials, LLCNorth Las Vegas, Egyesült ÁllamokNo longer taking part
- Sensible Healthcare, LLCOcoee, Egyesült ÁllamokNo longer taking part
- Clinical Neuroscience Solutions Inc. dba CNS HealthcareOrlando, Egyesült ÁllamokNo longer taking part
- Clinical Neuroscience Solutions, Inc.Orlando, Egyesült ÁllamokNo longer taking part
- Neuroscience Research Center, LLCOverland Park, Egyesült ÁllamokNo longer taking part
- Arthritis GroupPhiladelphia, Egyesült ÁllamokNo longer taking part
- Elite Clinical Studies, LLCPhoenix, Egyesült ÁllamokNo longer taking part
- Progressive Medical ResearchPort Orange, Egyesült ÁllamokNo longer taking part
- Accellacare of RaleighRaleigh, Egyesült ÁllamokNo longer taking part
- Raleigh Medical GroupRaleigh, Egyesült ÁllamokNo longer taking part
- Health ConceptsRapid City, Egyesült ÁllamokNo longer taking part
- Wasatch Clinical ResearchSalt Lake City, Egyesült ÁllamokNo longer taking part
- Acclaim Clinical Research, Inc.San Diego, Egyesült ÁllamokNo longer taking part
- Dr. Hans Richard Barthel, MD Office OfSanta Barbara, Egyesült ÁllamokNo longer taking part
- Gulfcoast Research InstituteSarasota, Egyesült ÁllamokNo longer taking part
- Sundance Clinical Research, LLCSt Louis, Egyesült ÁllamokNo longer taking part
- University Orthopedics CenterState College, Egyesült ÁllamokNo longer taking part
- Medvin Clinical ResearchThousand Oaks, Egyesült ÁllamokNo longer taking part
- Westlake Medical ResearchThousand Oaks, Egyesült ÁllamokNo longer taking part
- Oakland Medical Research CenterTroy, Egyesült ÁllamokNo longer taking part
- Noble Clinical ResearchTucson, Egyesült ÁllamokNo longer taking part
- Tucson Orthopaedic Research CenterTucson, Egyesült ÁllamokNo longer taking part
- Upstate Clinical Research AssociatesWilliamsville, Egyesült ÁllamokNo longer taking part
- Chan Soon-Shiong Medical Center at WindberWindber, Egyesült ÁllamokNo longer taking part
- Accellacare Research of Winston SalemWinston-Salem, Egyesült ÁllamokNo longer taking part
- Gastroenterology Associates of the PiedmontWinston-Salem, Egyesült ÁllamokNo longer taking part
- The Center for Clinical ResearchWinston-Salem, Egyesült ÁllamokNo longer taking part
- North Georgia Clinical ResearchWoodstock, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Grünenthal GmbH
- Azonosító
- NCT05449132
- A regiszteradat frissítve
- 2026. március 18.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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
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.
Bevonási feltételek: 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.
Kizáró feltételek: The participant has past joint replacement surgery of the index knee; The participant is currently participating or was participating in another investigational drug trial within 3 months prior to the Screening Visit; 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 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 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 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 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 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.