A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee
NCT ID: NCT03231280
Last Updated: 2018-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2017-08-14
2018-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SB-061
SB-061
SB-061
delivered via intra-articular injection
Placebo
Placebo
Placebo
Placebo delivered via intra-articular injection
Interventions
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SB-061
delivered via intra-articular injection
Placebo
Placebo delivered via intra-articular injection
Eligibility Criteria
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Inclusion Criteria
* Radiological OA Kellgren-Lawrence grade 2 or 3
* WOMAC Pain 1 score of the target knee of ≥4 and ≤ 9
Exclusion Criteria
* 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
40 Years
85 Years
ALL
No
Sponsors
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Nordic Bioscience A/S
INDUSTRY
Symic OA Co.
INDUSTRY
Responsible Party
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Principal Investigators
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Nathan Bachtell, MD
Role: STUDY_DIRECTOR
Symic OA Co.
Locations
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CCBR
Tallinn, , Estonia
Medita Kliinik
Tartu, , Estonia
Countries
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Other Identifiers
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TP-1803
Identifier Type: -
Identifier Source: org_study_id
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