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| Name | Class |
|---|---|
| Syreon Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EP-104IAR | Experimental | 15mg EP-104IAR in 4 mL carrier fluid |
|
| Vehicle | Placebo Comparator | 4 mL carrier fluid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EP-104IAR | Drug | Single, ultrasound-guided injection of EP-104IAR into the knee |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Helliwell, MD FRCPC | Eupraxia Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rebalance MD | Victoria | British Columbia | Canada | |||
| Centre for Studies in Family Medicine |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Vehicle |
| Drug |
Single, ultrasound-guided injection of vehicle placebo into the knee |
|
| Change from baseline in patient-reported 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 |
| 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 |
| London |
| Ontario |
| N6A 3K7 |
| Canada |
| Fowler Kennedy Sports Medicine Clinic | London | Ontario | N6A 3K7 | Canada |