This trial is designed to evaluate the tolerability, safety and effectiveness of a novel pain management therapy in dogs with severe elbow dysplasia with osteoarthritis. The drug is administered as one-time intra-articular injections into both elbows in most dogs. The injection will be administered under sedation or general anesthesia. There is no placebo in this trial. An estimated 28 client-owned dogs with will be enrolled. Owners will be required to complete pain assessment surveys, track their dog’s activity through the use of an activity monitor worn on the dog’s collar, and record short at-home videos assessing the dog’s gait. The trial site will train the owners on all of these assessments. Trial visits include the dog’s initial consultation, treatment day (Day 0), and then recheck visits on Days 14, 28, 56, and 84. Medications targeted at the treatment of osteoarthritis/ elbow dysplasia associated pain, except for CBD and other cannabinoids, are acceptable provided they have been administered for at least 2 weeks prior to enrolling in the study.
The trial is fully funded for the full trial duration (84 days). Funding includes the initial consultation, the study treatment and administration, radiographs prior to treatment (if not performed within 4 months of enrollment), recheck visits, required bloodwork, and management of side effects that are thought to be directly related to the trial.
Trained veterinarians at the trial sites will evaluate each dog for eligibility.
Dogs are eligible if they meet the following inclusion criteria:
- Dog’s body weight 10-50 kg
- Dog has clinical signs and radiographic evidence of elbow dysplasia
- Dog is experiencing elbow-associated pain that is refractory to standard pain management or owner opts for pain management that is distinct from conventional treatments
Dogs are not eligible if they meet any of the following exclusion criteria:
- Dog has a life expectancy of < 3 months
- Dog has any underlying disease that will affect the study objectives or patient safety
- Dog has concurrent or prior immune-mediated or other disease resulting polyarthropathy
- Dog is impaired due to neurological disease or other orthopedic disease
- Dog is pregnant or lactating
- Dog is participating in another study
- Dog may be unavailable for the entire trial duration or is felt to be unsuitable by the investigator for any other reason
- Dog requires medications or supplements during the course of the study that interfere with the objectives of the study including but not limited to TRPV1 agonist or antagonist drugs that could interfere with RTX mode of action (such as cannabinoids like CBD and anandamide)
This clinical trial is offered at the following locations:
Peak Performance Veterinary Group
700 Summit Blvd.
Frisco, CO 80443
Veterinary Specialty and Emergency Center
625 Ridge Pike, Building B
Conshohocken, PA 19428
Animal Surgical Clinic of Seattle
14810 15th Ave. NE
Shoreline, WA 98155
Quakertown Veterinary Clinic
2250 N. Old Bethlehem Pike
Quakertown, PA 18951
Colorado Canine Orthopedics
5528 N. Nevada Ave.
Colorado Springs, CO 80918
Boston West Veterinary Emergency and Specialty
5 Strathmore Rd
Natick, MA 01760