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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03231280 |
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Date of registration:
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20/07/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee
MODIFY2 |
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Scientific title:
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A Placebo-controlled, Double-blind, Randomized Trial of a Single Intra-articular Delivery of SB-061 for the Treatment of Symptomatic Osteoarthritis of the Knee |
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Date of first enrolment:
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August 14, 2017 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03231280 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Estonia
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Contacts
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Name:
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Nathan Bachtell, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Symic OA Co. |
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Key inclusion & exclusion 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
Age minimum:
40 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Intervention(s)
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Other: Placebo
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Device: SB-061
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Primary Outcome(s)
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Incidence of Treatment-Emergent Adverse Events
[Time Frame: Through 4 weeks]
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Pain
[Time Frame: Baseline, 4 weeks]
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Secondary Outcome(s)
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Physical function
[Time Frame: Baseline, 4 weeks]
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Pain
[Time Frame: Baseline, 4 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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