Trial | NCT02609126  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fluticasone ...

  • Study Participants

    32
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.
Study Started
Apr 30
2016
Primary Completion
Dec 28
2017
Study Completion
Dec 28
2017
Last Update
Sep 01
2021

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

EP-104IAR Experimental

15mg EP-104IAR in 4 mL carrier fluid

Vehicle Placebo Comparator

4 mL carrier fluid

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
No Results Posted