A Trial of SB-061 in Osteoarthritis of the Knee

Study Overview
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Brief Summary
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This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee. Half of the patients will receive the agent via intra-articular injection and half will receive a placebo injection.

Detailed Description
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The treatment of pain associated with osteoarthritis may include periodic intra-articular injections of corticosteroids or viscosupplements such as hyaluronic acid. SB-061 is anticipated to relieve osteoarthritis pain by reinforcing the cartilage matrix and providing a lubricating coating of the cartilage. Subjects will receive 2 intra-articular injections of either SB-061 or placebo and be followed for 3 months to evaluate pain amelioration. Subjects and Investigators are blinded to treatment allocation.

Official Title
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A Placebo-controlled, Double-blind, Randomized Trial of an Intra-articular Device, SB-061, in Symptomatic Osteoarthritis of the Knee

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: SB-061
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Femorotibial osteoarthritis of the knee Radiological OA Kellgren-Lawrence grade 2 or 3 WOMAC Pain 1 score of the target knee of ≥4 and ≤ 9 Exclusion Criteria: Hypersensitivity to medications or to intra-articular injections Intra-articular delivery of corticosteroids or hyaluronic acid in the target knee within 6 months of study High dose systemic corticosteroid treatment of longer (>14 days) duration w/in 6 months of study Major surgery or arthroscopy of the target knee within year prior to study Planned surgery in the target knee within the next 3 months Concomitant inflammatory disease affecting either knee

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB-061<br>SB-061 | Device: SB-061<br>* delivered via intra-articular injection<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain (A1) scores from baseline to 3 months post treatment will be compared between treatment and control groups. | Baseline, 3 months | 
| Incidence of Treatment-Emergent Adverse Events | A summary of Treatment-Emergent Adverse Events will be reported | Through 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) sub-scores scores related to pain from baseline to 3 months post treatment will be compared between treatment and control groups. | Baseline, 3 months | 
| Physical function | Change in Patient Global Assessement scores from baseline to 3 months post treatment will be compared between treatment and control groups. | Baseline, 3 months | 
| Pain | Change in Numeric Rating Scale (NRS) of pain from baseline to 3 months post treatment will be compared between treatment and control groups. | Baseline, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee