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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-12-28

Brief Summary

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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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Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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EP-104IAR

15mg EP-104IAR in 4 mL carrier fluid

Group Type EXPERIMENTAL

EP-104IAR

Intervention Type DRUG

Single, ultrasound-guided injection of EP-104IAR into the knee

Vehicle

4 mL carrier fluid

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Single, ultrasound-guided injection of vehicle placebo into the knee

Interventions

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EP-104IAR

Single, ultrasound-guided injection of EP-104IAR into the knee

Intervention Type DRUG

Vehicle

Single, ultrasound-guided injection of vehicle placebo into the knee

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No