This trial is designed to evaluate the tolerability, safety and effectiveness of a novel pain management therapy in dogs with chronic or refractory pain associated with bone tumors distal to the elbow. The drug is administered as 2 perineural injections in a single treatment. The injections will be administered under general anesthesia. There is no placebo in this trial. An estimated 12 client-owned dogs with pain associated with bone tumors distal to the elbow will be enrolled at 2 different locations in the U.S. Owners will be required to complete pain assessment surveys 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 7, 14, 28, and 56. If the dog is receiving bisphosphonates or radiation therapy, a 28-day washout is required prior to enrollment. Other pain medication(s) are accepted so long as the dog has been receiving a consistent regimen for at least 14 days prior to enrollment.
The trial is fully funded for the full trial duration (56 days). Funding includes the initial consultation, the study treatment and administration, radiographs prior to treatment (if not performed within 2 weeks 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:
- Owner or owner’s agent has provided written informed consent
- Dog’s body weight is equal to or greater than 20 kg and less than or equal to 50 kg
- Investigator has documented cytological or histological diagnosis of primary appendicular bone cancer or strong suspicion of bone cancer based on radiographs, MRI or CT scan
- Dog’s cancer affects the thoracic limb distal to the elbow with no known metastasis to other bones
- Dog has a lameness score of 2 or higher as determined by the Investigator
Dogs are not eligible if they meet any of the following exclusion criteria:
- Dog’s life expectancy less than 2 months
- Dog has an underlying disease that may, as determined by the Investigator in consultation with the Sponsor and/or medical director, affect the study objectives or patient safety
- Dog is receiving bisphosphonates or radiation therapy. If dog has received either of these therapies, a 28-day washout is required prior to enrollment. Other pain medication(s) are accepted so long as the dog has been receiving a consistent regimen for at least 14 days prior to enrollment
- Dog has evidence of a pathological fracture
- Dog is participating in another study
- Dog may not be available for the entire study duration
- Investigator feels the dog or owner is not well suited to the study for another reason
This clinical trial is offered at the following locations:
Hope Veterinary Specialists
40 Three Tun Road
Malvern, PA 19355
Veterinary Specialty Hospital of San Diego
10435 Sorrento Valley Rd.
San Diego, CA 92121