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

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT05449132

Run by

Grünenthal GmbH

People needed

466

Starts

2022-09-26

Expected to finish

2024-08-15

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Achieve Clinical Research, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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