SI-613 Study for Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Repeated Intra-Articular Injection of SI-613 in Patients With Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209362
• Other study ID #: 613 /1121
• Status: Completed
• Phase: Phase 2
• Start date: October 19, 2017
• Est. completion date: November 13, 2018

Study information

• Verified date: November 2021
• Source: Seikagaku Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 13, 2018
• Est. primary completion date: August 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Combination Product:
• SI-613
SI-613 will be repeated intra-articularly administered.
• Placebo
Placebo will be repeated intra-articularly administered.

Locations

Country	Name	City	State
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Central Kentucky Research Associates	Lexington	Kentucky
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	Rochester Clinical Research	Rochester	New York
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	Tucson Orthopaedic Institute	Tucson	Arizona
United States	Upstate Clinical Research Associates, LLC	Williamsville	New York

Sponsors (2)

Lead Sponsor	Collaborator
Seikagaku Corporation	Chiltern International Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore 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.	Baseline over 12 weeks
Secondary	Change From Baseline in WOMAC Pain Subscore at 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.	Baseline, Weeks 12 and 26
Secondary	Change From Baseline in WOMAC Physical Function Subscore at 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.	Baseline, Weeks 12 and 26
Secondary	Change From Baseline in WOMAC Stiffness Subscore at 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.	Baseline, Weeks 12 and 26
Secondary	Change From Baseline in WOMAC Total Score at 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.	Baseline, Weeks 12 and 26