This study is designed to evaluate the tolerability, safety and effectiveness of a novel therapy (not yet approved by FDA) to manage various painful conditions in dogs. Examples include bone tumors, chronic orthopedic pain refractory to conventional treatment, and oral tumors. The investigational drug is administered as a peri-nerual injection via a situationally appropriate nerve block. There is no placebo treatment. The one-time treatment will be administered under sedation or general anesthesia to approximately 15 client-owned dogs. Owners are required to complete periodic pain assessment surveys and record short at-home videos assessing their dog’s daily activities. The study staff will train owners on how to complete the assessments. Study visits include the dog’s initial consultation, treatment day (Day 0), and then recheck visits on Days 7, 14, 21, 28, and 56. During the course of the study, dogs are permitted to continue other pain medications provided they have been administered for at least 2 weeks prior to enrollment, and are not thought to be continuously improving pain symptoms. If the treated condition is cancer, no new anti-cancer therapy should be administered within 21 days of enrollment.
The study is fully funded for its entire duration (approximately 56 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:
- The dog is at least 6 months of age
- Historical evidence of a localized severe painful condition, reported by owner, but confirmed by the study veterinarian based on a specific pain scale
- In general, good health or stabilized for chronic conditions as assessed by physical examination, medical history and clinical pathology evaluations
- Dog is experiencing severe locoregional pain that is refractory to standard pain management or the 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 that is pregnant or lactating
- Dog has clinical pathology findings considered abnormal and clinically significant that may interfere with the objectives of the study
- Dog has a condition or requires medications that may interfere with anesthesia safety
- Dog’s life expectancy is less than 2 months
- Dog may be unavailable for the entire study duration or is felt to be unsuitable by the investigator for any other reason
- Dog has acute locoregional pain due to an infection that requires treatment with antibiotics
- Dog has evidence of a pathological fracture (cancer)
- Dog is participating in another study
- Dog that requires medications or supplements that interfere with the objectives of the study including but not limited to TRPV1 agonist or antagonist drug that could interfere with RTX mode of action (such as cannabinoids like CBD and anandamide)
Raphael Vezina-Audette, DVM, MSc
315 Robbinsville-Allentown Rd.
Robbinsville, NJ, 08691