Status:
COMPLETED
A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee
Lead Sponsor:
Symic OA Co.
Collaborating Sponsors:
Nordic Bioscience A/S
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-85 years
Phase:
PHASE1
PHASE2
Brief Summary
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 i...
Detailed Description
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 os...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 27 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03231280
Start Date
August 14 2017
End Date
March 27 2018
Last Update
April 19 2018
Active Locations (2)
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1
CCBR
Tallinn, Estonia, 10128
2
Medita Kliinik
Tartu, Estonia, 50107