NCT02609126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2017

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

1.7 years

First QC Date

November 17, 2015

Last Update Submit

August 30, 2021

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritisknee

Outcome Measures

Primary Outcomes (5)

  • Peak Plasma Concentration (Cmax) of fluticasone propionate

    Up to 42 weeks

  • Fluticasone propionate concentrations in synovial fluid

    Up to 30 weeks

  • Area under the plasma concentration versus time curve (AUC) of fluticasone propionate

    12 weeks

  • Incidence of treatment-emergent adverse events

    Up to 42 weeks

  • Change from baseline in clinical laboratory parameters: hematology, chemistry (including cortisol) and urinalysis

    Up to 42 weeks

Secondary Outcomes (6)

  • Time to baseline pain in patient-reported Pain Numerical Rating Scale for Index knee

    Weekly up to 42 weeks

  • Change from baseline in patient-reported Pain Numerical Rating Scale for Index knee

    Weekly up to 42 weeks

  • Change from baseline in patient-reported Global Assessment of Arthritis

    Up to 42 weeks

  • Change from baseline in patient-reported Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Up to 42 weeks

  • Change from baseline in patient-reported Short Form - 36 quality of life scores

    Up to 42 weeks

  • +1 more secondary outcomes

Study Arms (2)

EP-104IAR

EXPERIMENTAL

15mg EP-104IAR in 4 mL carrier fluid

Drug: EP-104IAR

Vehicle

PLACEBO COMPARATOR

4 mL carrier fluid

Drug: Vehicle

Interventions

EP-104IARDRUG

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

EP-104IAR
VehicleDRUG

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

Vehicle

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rebalance MD

Victoria, British Columbia, Canada

Location

Centre for Studies in Family Medicine

London, Ontario, N6A 3K7, Canada

Location

Fowler Kennedy Sports Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • James Helliwell, MD FRCPC

    Eupraxia Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 20, 2015

Study Start

April 1, 2016

Primary Completion

December 28, 2017

Study Completion

December 28, 2017

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

CA(3)