This is an exploratory study to evaluate the safety and effectiveness of concomitant intra-articular (IA) and peri-neural (PN) injections of an investigational veterinary product for the control of elbow pain in dogs. This 28-day study also includes a long term follow up at 3 and 6 months. This study involves a one-time injectable treatment with investigational product under general anesthesia or sedation. This study does include a control group. An estimated 20 client-owned dogs will be enrolled. Owners will be required to report and record abnormal daily observations and complete questionnaires relating to dog’s pain level throughout the study. Study visits include the dog’s initial consultation, treatment Day 0, recheck visits on Day 7, 28, 90, and 180.
The study is fully funded for the entire duration of 28 days including the 3 and 6 month follow up visits. Funding includes the initial consultation, the study treatment and administration, recheck visits, and management of side effects that are thought to be directly related to participation in the study.
Dogs are eligible if they meet the following inclusion criteria:
- In general good health or stabilized for chronic conditions
- Has body weight of at least 15 kg or higher
- Has clinically documented articular pain originating in at least one elbow and the only joint on that limb to show signs of pain
- Has history of persistent lameness due to elbow pain for at least 2 months prior to enrollment
- Any medication used for the treatment of pain has been discontinued at least 10 days prior to screening
- In case of bilateral elbow pain, the most clinically affected joint will be selected.
Dogs are not eligible if they meet the following exclusion criteria:
- Dog is < 1 year of age
- Dog is intended for breeding or is a pregnant or lactating female dog
- Pain is not related to elbow joint
- The elbow to be treated is NOT the only joint with pain on that limb
- The elbow pain is related to intra-articular or peri-articular tumors, recent trauma (less than 2 months), or unhealed fractures (excluding fragmented medial coronoid process)
- The elbow pain is related to active or actively treated immune mediated joint diseases
- The dog has undergone medical or surgical procedure that may affect study assessments within 120 days prior to enrollment
- The dog has medical conditions or has been given medications that may interfere with treatment assessment or anesthesia safety
Cornell University Hospital for Animals
930 Campus Rd
Ithaca, NY 14853
Veterinary Specialty Hospital
10435 Sorrento Valley Rd
San Diego, CA 92121
Additional study sites coming soon!
If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.