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

Study results available
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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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02110238 on ClinicalTrials.gov