Non-Inferiority Study Comparing 3 Weekly Injections of SUPARTZ® vs 3 Weekly Injections of Euflexxa® for Knee OA
NCT02110238 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 421
Last updated 2021-03-09
Summary
The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief of knee OA.
Conditions
Interventions
- DEVICE
-
Supartz
Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
- DEVICE
-
Euflexxa
Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
Sponsors & Collaborators
-
Seikagaku Corporation
collaborator INDUSTRY -
Bioventus LLC
lead INDUSTRY
Principal Investigators
-
Vibeke Strand, MD · Stanford University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2014-11-30
- Completion
- 2015-02-28
Countries
- United States
Study Locations
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