SI-613 Study for Knee Osteoarthritis

Phase 2

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Combination Product: Placebo; Combination Product: SI-613

• Registration Number: NCT03209362
• Lead Sponsor: Seikagaku Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-06
• Study Start: 2017-10-19
• Primary Completion: 2018-08-17
• Study Completion: 2018-11-13
• Disposition First Submitted: 2018-11-26
• Results First Submitted: 2021-08-16
• Results First Submitted QC: 2021-09-13
• Disposition First Submitted QC: 2021-09-13
• Results First Posted: 2021-09-16
• Disposition First Posted: 2021-09-16
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
SI-613	SI-613	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks	Baseline over 12 weeks	Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline over 12 weeks was analyzed using a repeated measures Analysis of Covariance (ANCOVA) model.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26	Baseline, Weeks 12 and 26	Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26	Baseline, Weeks 12 and 26	Observed VAS of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26	Baseline, Weeks 12 and 26	Observed VAS of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Change From Baseline in WOMAC Total Score at Weeks 12 and 26	Baseline, Weeks 12 and 26	WOMAC total score was the mean of WOMAC pain, physical function and stiffness subscores and ranges from 0 to 100 mm, where higher scores indicated worse response. Changes in WOMAC total score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.

Trial Locations

Locations (10)

MM Medical Center, Inc.; 🇺🇸 Miami, Florida, United States

Heartland Research Associates, LLC; 🇺🇸 Newton, Kansas, United States

Sundance Clinical Research, LLC; 🇺🇸 Saint Louis, Missouri, United States

Tucson Orthopaedic Institute; 🇺🇸 Tucson, Arizona, United States

Rochester Clinical Research; 🇺🇸 Rochester, New York, United States

Quality Research and Medical Center, LLC; 🇺🇸 Miami, Florida, United States

Central Kentucky Research Associates; 🇺🇸 Lexington, Kentucky, United States

New Horizons Clinical Research; 🇺🇸 Cincinnati, Ohio, United States

Upstate Clinical Research Associates, LLC; 🇺🇸 Williamsville, New York, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States