Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2017-10-19
2018-11-13
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SI-613
SI-613
SI-613 will be repeated intra-articularly administered.
Placebo
Placebo
Placebo will be repeated intra-articularly administered.
Interventions
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SI-613
SI-613 will be repeated intra-articularly administered.
Placebo
Placebo will be repeated intra-articularly administered.
Eligibility Criteria
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Inclusion Criteria
* Has a diagnosis at the time of screening of OA of the knee according to American College of Rheumatology (ACR) criteria
* Is willing to switch to using acetaminophen as a rescue medication
Exclusion Criteria
* Secondary OA
* Is a female subject who is pregnant or lactating.
* Is currently hospitalized or has a planned hospitalization during the life of the study.
40 Years
75 Years
ALL
No
Sponsors
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Chiltern International Inc.
INDUSTRY
Seikagaku Corporation
INDUSTRY
Responsible Party
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Locations
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Tucson Orthopaedic Institute
Tucson, Arizona, United States
MM Medical Center, Inc.
Miami, Florida, United States
Quality Research and Medical Center, LLC
Miami, Florida, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
Central Kentucky Research Associates
Lexington, Kentucky, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Rochester Clinical Research
Rochester, New York, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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613 /1121
Identifier Type: -
Identifier Source: org_study_id