Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis

• Status: Completed
• Trial end date: 2017-12-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eupraxia Pharmaceuticals Inc.
• Collaborator: Syreon Corporation

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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