The study is evaluating the short and long term (90 days) effect of this drug after a single injection in the elbow joints. This clinical trial is part of the normal FDA approval process of demonstrating that the new drug is effective and safe for use in dogs. There are no costs for pet owners related to study participation.
This study aims to confirm the effectiveness and safety of a new medicine to control pain associated with osteoarthritis of the elbow in dogs. If your dog qualifies for this study, you should expect to stay in the study for 90 days and have 7 scheduled visits with the veterinarian conducting the study. You will also be required to provide weekly behavioral assessments of your dog.
Because this is a study that is intended to support the drug’s approval, it needs to be “controlled.” This means some dogs receive treatment and others undergo the preparation and everything leading up to an injection of the medication, but do not actually receive the medication being tested. This study is also “blinded” or “masked,” meaning neither you nor the veterinarian making observations will know if your dog received the treatment or not until the end of the study. All owners of untreated dogs will be given an opportunity at the end of the study for their dogs to receive the investigational treatment at no charge.
If you decide to enroll your dog in this study, he/she will receive all study-related care at no cost to you.
In addition, as participants in this study, you and your dog will be helping advance both human and veterinary medicine and treatments for future generations of owners and their animals.