Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis
- Registration Number
- NCT02609126
- Lead Sponsor
- Eupraxia Pharmaceuticals Inc.
- Brief Summary
The main purpose of this study is to understand the pharmacokinetics of EP-104IAR and to determine whether it is safe to use in patients with osteoarthritis (OA) of the knee. The study will also provide some preliminary insights into whether the experimental treatment reduces pain in the knee.
Osteoarthritis is the most common joint disease, affecting over 20 million people in the US alone. Currently, pain treatments that are injected directly into the knee often work for only a short time and may also have side effects within the rest of the body. The experimental treatment is a steroid that is in the same family of drugs as the most common current injectable treatments for knee osteoarthritis. For this study, the drug is coated with a polymer intended to prolong the time it stays inside the knee and lessen potential side effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- OA of Index Knee
- Kellgren Lawrence Grade 2 or 3
- Patient-reported pain (PtPain) of Index Knee ≥4 but ≤9
- PtPain of non-Index Knee <6
- BMI ≦ 40 kg/m2
- Intra-articular joint injection in the Index Knee within the past 8 weeks for glucocorticoids and 6 months for hyaluronic acid
- Insulin-dependent diabetes
- Active infection
- Pregnant or breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EP-104IAR EP-104IAR 15mg EP-104IAR in 4 mL carrier fluid Vehicle Vehicle 4 mL carrier fluid
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) of fluticasone propionate Up to 42 weeks Fluticasone propionate concentrations in synovial fluid Up to 30 weeks Area under the plasma concentration versus time curve (AUC) of fluticasone propionate 12 weeks Incidence of treatment-emergent adverse events Up to 42 weeks Change from baseline in clinical laboratory parameters: hematology, chemistry (including cortisol) and urinalysis Up to 42 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in patient-reported Short Form - 36 quality of life scores Up to 42 weeks Change from baseline in Physician's Global Assessment of Arthritis Up to 42 weeks Change from baseline in patient-reported Western Ontario and McMaster Universities Arthritis Index (WOMAC) Up to 42 weeks Time to baseline pain in patient-reported Pain Numerical Rating Scale for Index knee Weekly up to 42 weeks Change from baseline in patient-reported Pain Numerical Rating Scale for Index knee Weekly up to 42 weeks Change from baseline in patient-reported Global Assessment of Arthritis Up to 42 weeks
Trial Locations
- Locations (3)
Centre for Studies in Family Medicine
🇨🇦London, Ontario, Canada
Fowler Kennedy Sports Medicine Clinic
🇨🇦London, Ontario, Canada
Rebalance MD
🇨🇦Victoria, British Columbia, Canada