Clinical trial NCT02609126: Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis
knee
Lead sponsor: Eupraxia Pharmaceuticals Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syreon Corporation
First posted: 2015-11-20
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of fluticasone propionate
timeFrame: Up to 42 weeks
measure: Fluticasone propionate concentrations in synovial fluid
timeFrame: Up to 30 weeks
measure: Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
timeFrame: 12 weeks
measure: Incidence of treatment-emergent adverse events
timeFrame: Up to 42 weeks
measure: Change from baseline in clinical laboratory parameters: hematology, chemistry (including cortisol) and urinalysis
timeFrame: Up to 42 weeks
Secondary outcomes:
measure: Time to baseline pain in patient-reported Pain Numerical Rating Scale for Index knee
timeFrame: Weekly up to 42 weeks
measure: Change from baseline in patient-reported Pain Numerical Rating Scale for Index knee
timeFrame: Weekly up to 42 weeks
measure: Change from baseline in patient-reported Global Assessment of Arthritis
timeFrame: Up to 42 weeks
measure: Change from baseline in patient-reported Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Up to 42 weeks
measure: Change from baseline in patient-reported Short Form - 36 quality of life scores
timeFrame: Up to 42 weeks
measure: Change from baseline in Physician's Global Assessment of Arthritis
timeFrame: Up to 42 weeks
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Rebalance MD
state: British Columbia
city: London
country: Canada
facility: Centre for Studies in Family Medicine
state: Ontario
city: London
country: Canada
facility: Fowler Kennedy Sports Medicine Clinic
state: Ontario
Study officials:
affiliation: Eupraxia Pharmaceuticals
name: James Helliwell, MD FRCPC
role: STUDY_DIRECTOR
References: