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

NCT02609126 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-09-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Syreon Corporation

    collaborator INDUSTRY

  • Eupraxia Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • James Helliwell, MD FRCPC · Eupraxia Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-12-28
Completion
2017-12-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02609126 on ClinicalTrials.gov