Evaluating a Therapeutic Drug in Dogs with Elbow or Stifle Osteoarthritis
Pilot Field Study to Evaluate the Efficacy and Clinical Safety of a Novel Oral Therapeutic Drug in Dogs with Elbow or Stifle Osteoarthritis
Purpose of study
This study is a blinded, placebo-controlled study, to test the efficacy of pain relief of the new drug, in dogs with elbow or stifle osteoarthritis.
Osteoarthritis is a commonly occurring chronic illness in humans and animals alike. Among all domestic and pet animal species, dogs suffer from arthritis more often because of excessive running or exercise, injury, and/or genetic predisposition. Presently, one in four (25%) of 77.2 million pet dogs in the United States are diagnosed with some form of arthritis. In dogs, osteoarthritis is more common than rheumatoid arthritis and pain is the number one observation. Osteoarthritis, also known as degenerative joint disease (DJD), is a slowly progressive inflammatory disease, which causes significant changes to the underlying tissues and cell signaling pathways within the joint, leading to a perpetual destructive cycle. We are testing a new medicine, which targets one of the pathways within this perpetual destructive cycle, to help alleviate the pain associated with osteoarthritis.
Dogs with clinically relevant radiographic elbow or stifle osteoarthritis (lameness in one or both forelimbs or hindlimbs).
We are screening dogs for inclusion in our study that meet the following criteria. The Study veterinarian can discuss with you further requirements for the study.
Dogs must be:
- At least 2 years old
- Any breed or sex
- Body weight from 33 to 110 lbs (15 to 50 kg)
- Diagnosed osteoarthritis in one or both forelimbs OR hindlimbs (x-ray)
- Mild to moderate lameness in one or both forelimbs OR hindlimbs
Dogs not eligible for the study:
- Breeding males
- Breeding, lactating or pregnant females
- Fractious, aggressive or frightened dogs
- Dogs with uncontrolled systemic disease (e.g. endocrine disorders, heart failure, kidney disease)
- Dogs in poor health condition
- Dogs with neurological disease
- Dogs with any surgery in the previous 120 days
- Dogs with osteoarthritis in BOTH forelimbs and hindlimbs
The Study veterinarian will conduct other assessments and collect medical history and medication history to evaluate the eligibility of your dog for the study.
This study will require four visits to the clinic:
- Day -7 (Initial screening visit): physical examination, radiographs of both forelimbs or hindlimbs (if none available), gait analysis, blood and urine samples collected to help determine if your dog is eligible for enrollment. You will have a chance to discuss the study with the veterinarian.
- Day 0 (Enrollment visit): physical examination, lameness assessments by the owner, lameness assessments by the veterinarian and gait analysis. If the dog meets all enrollment criteria and the owner consents to treatment, then treatment will be started. Treatment will be administered by the owner for 15 days at home.
- Day 15: physical examination, lameness assessments by the owner, lameness assessments by the veterinarian, gait analysis, blood samples collected. End of treatment.
- Day 29 (Follow-up visit after treatment): physical examination, blood and urine samples collected. End of study.
The study visits as described above will be paid for by the study. At the final visit, owners will be eligible to receive a $200 debit card.