The purpose of this study is to evaluate the safety and analgesic effect of a novel therapy topically administered for the control of pain associated with Feline Chronic Gingivostomatitis, or FCGS. The study involves a one-time treatment with an investigational product administered topically to the oral lesions. The treatment will be administered under sedation or general anesthesia. This study does not contain a placebo group. An estimated 40 client-owned cats will be enrolled. Owners will be required to complete daily observation logs for the duration of the study. Study visits include the cats’ initial consultation, treatment day (Day 0), and then recheck visits on Days 7, 14, and 28.
The study is fully funded for the full study duration (28 days). Funding includes the initial consultation, the study treatment and administration, short-acting analgesic therapy for three days post-treatment (as needed), recheck visits, required bloodwork, and management of side effects that are thought to be directly related to participation in the study.
Trained veterinarians at the study sites will evaluate each cat for eligibility. Cats are eligible if they meet the following inclusion criteria:
- The cat has documented diagnosis of FCGS.
- The cat is experiencing FCGS clinical signs related to oral pain for at least 3 months following the diagnosis of FCGS.
- The owner expresses that the cat has experienced a significant decrease in quality of life due to oral pain or is considering euthanasia due to clinical signs related to oral pain (i.e., pain is negatively impacting quality of life).
- Medications commonly used for the treatment of pain, except for corticosteroids (see Exclusion Criteria), are acceptable provided they have been administered for at least 2 weeks prior to enrolling in the study, and no changes in regimen are expected while the cat is in the study.
- The cat meets the minimum pain scale requirements, as assessed by the study Veterinarian.
Cats are not eligible if they meet any of the following exclusion criteria:
- The cat is less than 12 months of age.
- The cat’s body weight is less than 2 kg.
- The cat is unlikely to survive a 30-minute anesthesia or sedation procedure.
- The cat would be unlikely to survive 4-weeks due to health issues other than oral pain.
- The cat may be unavailable for the entire study duration or is felt to be unsuitable by the Investigator for another reason.
- The cat is participating in another study.
- The cat is pregnant or lactating.
- The cat has received oral corticosteroids within 1 week of starting the study or injectable corticosteroids within 6 weeks of starting the study and/or requires medication or supplements during the study that may interfere with the objective of the study.
- The cat has received cannabinoid agonists such as cannabidiol (CBD) or anandamide within 28 days of starting the study.
- The cat underwent an oral surgical procedure within 30 days prior screening.
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