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CompletedPhase 3

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

Key facts

Who runs it
Grünenthal GmbH
Where
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, and Woodstock, United StatesSee the 55 sitesAlso in 4 other countries, 25 sites
Trial code
Status
Completed
Phase
Phase 3
People taking part
466 people enrolled
Started
26 Sept 2022
Ended
15 Aug 2024
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • RTX-GRT7039
  • Placebo
Record updated
18 March 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in United States

Also in 4 other countries, 25 sites

  • Albuquerque Clinical Trials, Inc.Albuquerque, United StatesNo longer taking part
  • University Orthopedics CenterAltoona, United StatesNo longer taking part
  • Orange County Research InstituteAnaheim, United StatesNo longer taking part
  • Achieve Clinical Research, LLCBirmingham, United StatesNo longer taking part
  • Injury Care ResearchBoise, United StatesNo longer taking part
  • Core Health Care GroupCerritos, United StatesNo longer taking part
  • Accellacare Research of CharlotteCharlotte, United StatesNo longer taking part
  • Park Road Medical ClinicCharlotte, United StatesNo longer taking part
  • Charlottesville Medical Research Center, LLCCharlottesville, United StatesNo longer taking part
  • Chicago Clinical Research Institute INCChicago, United StatesNo longer taking part
  • Altoona Center For Clinical ResearchDuncansville, United StatesNo longer taking part
  • MediSphere Medical Research Center, LLCEvansville, United StatesNo longer taking part
  • Arizona Arthritis and Rheumatology Associates (AARA) P.CGlendale, United StatesNo longer taking part
  • PCPMG Clinical Research Unit, LLCGreenville, United StatesNo longer taking part
  • Drug Trials AmericaHartsdale, United StatesNo longer taking part
  • Chicago Medical Research LLCHazel Crest, United StatesNo longer taking part
  • Antria Inc.Indiana, United StatesNo longer taking part
  • Accellacare - KnoxvilleKnoxville, United StatesNo longer taking part
  • June DO, PCLansing, United StatesNo longer taking part
  • Excel Clinical ResearchLas Vegas, United StatesNo longer taking part
  • Allied Biomedical Research InstituteMiami, United StatesNo longer taking part
  • Well Pharma Medical Research Corp.Miami, United StatesNo longer taking part
  • Delricht ResearchNew Orleans, United StatesNo longer taking part
  • LCMC Health Urgent Care - LakeviewNew Orleans, United StatesNo longer taking part
  • Better Health Clinical Research, Inc.Newnan, United StatesNo longer taking part
  • Vista Clinical ResearchNewnan, United StatesNo longer taking part
  • Coastal Carolina Research CenterNorth Charleston, United StatesNo longer taking part
  • Las Vegas Clinical Trials, LLCNorth Las Vegas, United StatesNo longer taking part
  • Sensible Healthcare, LLCOcoee, United StatesNo longer taking part
  • Clinical Neuroscience Solutions Inc. dba CNS HealthcareOrlando, United StatesNo longer taking part
  • Clinical Neuroscience Solutions, Inc.Orlando, United StatesNo longer taking part
  • Neuroscience Research Center, LLCOverland Park, United StatesNo longer taking part
  • Arthritis GroupPhiladelphia, United StatesNo longer taking part
  • Elite Clinical Studies, LLCPhoenix, United StatesNo longer taking part
  • Progressive Medical ResearchPort Orange, United StatesNo longer taking part
  • Accellacare of RaleighRaleigh, United StatesNo longer taking part
  • Raleigh Medical GroupRaleigh, United StatesNo longer taking part
  • Health ConceptsRapid City, United StatesNo longer taking part
  • Wasatch Clinical ResearchSalt Lake City, United StatesNo longer taking part
  • Acclaim Clinical Research, Inc.San Diego, United StatesNo longer taking part
  • Dr. Hans Richard Barthel, MD Office OfSanta Barbara, United StatesNo longer taking part
  • Gulfcoast Research InstituteSarasota, United StatesNo longer taking part
  • Sundance Clinical Research, LLCSt Louis, United StatesNo longer taking part
  • University Orthopedics CenterState College, United StatesNo longer taking part
  • Medvin Clinical ResearchThousand Oaks, United StatesNo longer taking part
  • Westlake Medical ResearchThousand Oaks, United StatesNo longer taking part
  • Oakland Medical Research CenterTroy, United StatesNo longer taking part
  • Noble Clinical ResearchTucson, United StatesNo longer taking part
  • Tucson Orthopaedic Research CenterTucson, United StatesNo longer taking part
  • Upstate Clinical Research AssociatesWilliamsville, United StatesNo longer taking part
  • Chan Soon-Shiong Medical Center at WindberWindber, United StatesNo longer taking part
  • Accellacare Research of Winston SalemWinston-Salem, United StatesNo longer taking part
  • Gastroenterology Associates of the PiedmontWinston-Salem, United StatesNo longer taking part
  • The Center for Clinical ResearchWinston-Salem, United StatesNo longer taking part
  • North Georgia Clinical ResearchWoodstock, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • RTX-GRT7039Treatment being tested

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

  • PlaceboPlacebo, for comparison

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

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Record updated
18 March 2026