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

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ClinicalTrials.gov Identifier: NCT02110238
Recruitment Status : Completed
First Posted : April 10, 2014
Results First Posted : June 23, 2016
Last Update Posted : March 9, 2021
Sponsor:
Collaborator:
Seikagaku Corporation
Information provided by (Responsible Party):
Bioventus LLC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Supartz Device: Euflexxa Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 421 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Euflexxa
Euflexxa® (hyaluronic acid of bacterial origin)
 Device: Euflexxa
Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
Experimental: Supartz
SUPARTZ® (hyaluronic acid of avian origin)
 Device: Supartz
Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.


Outcome Measures
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Primary Outcome Measures :
  1. WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline [ Time Frame: Change from Baseline (CFB) over Weeks 3, 6, and 12 ]
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) 0-100mm Pain subscale score Change from Baseline (CFB). Over weeks 3, 6, and 12 least square mean difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (0mm:None - 100mm:Extreme) pain subscale score Change from Baseline (CFB). A single estimate of least squares mean was calculated using data from baseline, weeks 3, 6, and 12.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical evidence of symptomatic osteoarthritis of the study knee as classified according to Altman criteria.
  • Symptoms in study knee for at least one year prior to the screening visit
  • Verified OA of the study knee of Grade 2 or 3 according to a modification of the grading system of Kellgren-Lawrence (K-L) radiographic severity.
  • Willingness to discontinue NSAIDs (systemic and topical) and non-acetaminophen analgesic use seven days or five half-lives prior to the first injection and throughout the study.

Exclusion Criteria:

  • Inability to perform a 50 foot walk test.
  • Subjects with rheumatoid arthritis, joint infection, other inflammatory and metabolic arthritis, Lupus or dermatologic disorder or skin conditions in close proximity to study knee that would preclude safe intra-articular injections.
  • Prior hyaluronic acid injections into the study knee within six months of the screening visit.
  • Intra-articular or intra-muscular steroid injections within three months of the screening visit or during study participation. Oral corticosteroids within four weeks of the screening visit or during study participation.
  • History of surgical treatment to the study knee or arthroscopic intervention within three months prior to the screening visit.
  • Clinically apparent tense effusion of the study knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap).
  • Subjects with clinically diagnosed symptomatic OA of the hip.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110238


Locations
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United States, North Carolina
Triangle Orthopaedic Associates
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
Bioventus LLC
Seikagaku Corporation
Investigators
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Principal Investigator: Vibeke Strand, MD Stanford University
More Information
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Responsible Party: Bioventus LLC
ClinicalTrials.gov Identifier: NCT02110238    
Other Study ID Numbers: 13SUP301
First Posted: April 10, 2014    Key Record Dates
Results First Posted: June 23, 2016
Last Update Posted: March 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bioventus LLC:
osteoarthritis
knee pain
Supartz
 Euflexxa
HA
hyaluronic acid
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents