NCT02609126

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

A Randomized, Double-Blind, Placebo-Controlled, Phase I Trial Evaluating the Pharmacokinetics, Safety and Preliminary Efficacy of EP-104IAR (Long-Acting Fluticasone Propionate) in Patients With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Eupraxia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	EP-104IAR	Single, ultrasound-guided injection of EP-104IAR into the knee
DRUG	Vehicle	Single, ultrasound-guided injection of vehicle placebo into the knee

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-12-28
• Completion: 2017-12-28
• First posted: 2015-11-20
• Last updated: 2021-09-01

Locations

3 sites across 1 country: Canada