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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609126
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : September 1, 2021
Sponsor:
Collaborator:
Syreon Corporation
Information provided by (Responsible Party):
Eupraxia Pharmaceuticals Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: EP-104IAR Drug: Vehicle Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2016
Actual Primary Completion Date : December 28, 2017
Actual Study Completion Date : December 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: EP-104IAR
15mg EP-104IAR in 4 mL carrier fluid
 Drug: EP-104IAR
Single, ultrasound-guided injection of EP-104IAR into the knee
Placebo Comparator: Vehicle
4 mL carrier fluid
 Drug: Vehicle
Single, ultrasound-guided injection of vehicle placebo into the knee


Outcome Measures
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Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) of fluticasone propionate [ Time Frame: Up to 42 weeks ]
  2. Fluticasone propionate concentrations in synovial fluid [ Time Frame: Up to 30 weeks ]
  3. Area under the plasma concentration versus time curve (AUC) of fluticasone propionate [ Time Frame: 12 weeks ]
  4. Incidence of treatment-emergent adverse events [ Time Frame: Up to 42 weeks ]
  5. Change from baseline in clinical laboratory parameters: hematology, chemistry (including cortisol) and urinalysis [ Time Frame: Up to 42 weeks ]

Secondary Outcome Measures :
  1. Time to baseline pain in patient-reported Pain Numerical Rating Scale for Index knee [ Time Frame: Weekly up to 42 weeks ]
  2. Change from baseline in patient-reported Pain Numerical Rating Scale for Index knee [ Time Frame: Weekly up to 42 weeks ]
  3. Change from baseline in patient-reported Global Assessment of Arthritis [ Time Frame: Up to 42 weeks ]
  4. Change from baseline in patient-reported Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: Up to 42 weeks ]
  5. Change from baseline in patient-reported Short Form - 36 quality of life scores [ Time Frame: Up to 42 weeks ]
  6. Change from baseline in Physician's Global Assessment of Arthritis [ Time Frame: Up to 42 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609126


Locations
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Canada, British Columbia
Rebalance MD
Victoria, British Columbia, Canada
Canada, Ontario
Centre for Studies in Family Medicine
London, Ontario, Canada, N6A 3K7
Fowler Kennedy Sports Medicine Clinic
London, Ontario, Canada, N6A 3K7
Sponsors and Collaborators
Eupraxia Pharmaceuticals Inc.
Syreon Corporation
Investigators
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Study Director: James Helliwell, MD FRCPC Eupraxia Pharmaceuticals
More Information
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Responsible Party: Eupraxia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02609126    
Other Study ID Numbers: EP-104IAR-101
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Eupraxia Pharmaceuticals Inc.:
osteoarthritis
knee
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases