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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
CCBR
Tallinn, Estonia
Medita Kliinik
Tartu, Estonia
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.
Time frame: Baseline, 3 months
Incidence of Treatment-Emergent Adverse Events
A summary of Treatment-Emergent Adverse Events will be reported
Time frame: Through 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months
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