SI-613 Study for Knee Osteoarthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.

Key facts

Study ID

NCT03209362

Run by

Seikagaku Corporation

People needed

80

Starts

2017-10-19

Expected to finish

2018-11-13

Last updated by the study team

2021-11-04

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provides their written informed consent.
• 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

You may not qualify if…

• Has a body mass index (BMI) greater than or equal to 40 kg/m2 at screening.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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