Clinical Investigation Center
STEPS Study: A pilot dose confirmation study to evaluate the effectiveness and safety of intra-articular injection of CNTX-4975 for the control of pain associated with osteoarthritis in dogs
Current Status: Active and enrolling
Principal Investigator: Michael Conzemius, DVM, PhD, DACVS
Contact: Sara Pracht, Research Study Technician Specialist at 612-626-3574, email@example.com
Purpose of study:
Pain from osteoarthritis (OA) can restrict dogs from daily activities such as walking and climbing stairs. Pain relief currently available can be short-acting, cause side effects and not be effective in all dogs. The new treatment in this study is being studied to help provide long-lasting pain relief.
This is a 28-day, placebo-controlled study. Dogs will either receive the study medication injected into the joint most affected by OA, or a sham injection involving a needle being inserted but nothing injected. Dogs will be anesthetized for the intra-articular injection. The study team will be closely monitoring the dogs during and after treatment.
- Have moderate to severe signs of OA in a stifle (knee) or elbow joint for at least 3 months
- 1 year old or more
- Weigh 22 pounds (10 kg) or more
- No recent surgery or other invasive treatment to any joint
- No rupture of cranial cruciate ligament of either stifle within 60 days of study
- Otherwise good health
- Not on certain medications – call for details
Description of study:
- Two randomly assigned groups, 1 in 2 chance of receiving study drug
- Visits: four visits (screening, injection day (Day 0), rechecks at 2 weeks and 4 weeks)
- Procedures include physical and lameness exams, owner assessments, X-rays at screening, anesthesia and injection of a single joint, blood and urine sample collection at screening visit
- Owners will answer three questionnaires at each visit and maintain an owner observation record at home
- Telephone interviews: two interviews (7 days prior and after treatment), answering two questionnaires during each interview.
The study covers costs of the study medication, study related visits and tests. Owners who complete the study are eligible for a payment of $350.
For questions and to schedule an appointment, please contact Sara Pracht (see above).