A FUNDED CLINICAL TRIAL TO EVALUATE A NOVEL PAIN MANAGEMENT THERAPY IN DOGS WITH SEVERE ELBOW DYSPLASIAJanuary 25th, 2018 Posted by catharine Osteoarthritis, Pain Management, Pain Studies 0 thoughts on “A FUNDED CLINICAL TRIAL TO EVALUATE A NOVEL PAIN MANAGEMENT THERAPY IN DOGS WITH SEVERE ELBOW DYSPLASIA”
This study is designed to evaluate the tolerability, safety and effectiveness of a novel therapy (not yet approved by FDA) to manage pain associated with moderate to severe elbow dysplasia and secondary osteoarthritis in dogs. The investigational drug is administered as an intra-articular injection into both elbows. There is no placebo treatment. The one-time treatment will be administered under sedation or general anesthesia to approximately 28 client-owned dogs. Owners are required to complete periodic pain assessment surveys and record short at-home videos assessing the dog’s gait. The study staff will train owners on how to complete the assessments. The dog’s activity also will be tracked through the use of an activity monitor worn on the dog’s collar. Study 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 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 study is fully funded for its entire duration (approximately 84 days). Funding includes the initial consultation, the study treatment and administration, radiographs prior to treatment (if not already performed within 2 weeks of enrollment), recheck visits, required bloodwork, and management of side effects that are thought to be directly related to study participation.
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
Veterinary Specialty Hospital of San Diego
10435 Sorrento Valley Rd
San Diego, CA 92121