NCT02110238

Non-Inferiority Study Comparing 3 Weekly Injections of SUPARTZ® vs 3 Weekly Injections of Euflexxa® for Knee OA

Multicenter, Randomized, Double-Blind, Parallel Controlled Non-Inferiority Clinical Trial Comparing 3 Weekly Intra-articular Injections of SUPARTZ® vs 3 Weekly Intra-articular Injections of Euflexxa® for Treatment of Knee OA

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 421 (actual)
• Sponsor: Bioventus LLC · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 joint pain in subjects with osteoarthritis (OA) of the knee as measured by the VAS (0-100 mm) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale score Change from Baseline (CFB) over Weeks 3, 6, 12. Safety will be accessed by recording adverse events, concomitant medications, physical examinations, and vital signs.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-11-01
• Completion: 2015-02-01
• First posted: 2014-04-10
• Last updated: 2021-03-09
• Results posted: 2016-06-23

Locations

1 site across 1 country: United States