NCT03209362
Completed
Phase 2
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
ConditionsOsteoarthritis, Knee
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Seikagaku Corporation
- Enrollment
- 80
- Locations
- 10
- Primary Endpoint
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks
Time Frame: 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 Outcomes
- Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26(Baseline, Weeks 12 and 26)
- Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26(Baseline, Weeks 12 and 26)
- Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26(Baseline, Weeks 12 and 26)
- Change From Baseline in WOMAC Total Score at Weeks 12 and 26(Baseline, Weeks 12 and 26)
Study Sites (10)
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