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

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Supartz

Euflexxa

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring osteoarthritis, knee pain, Supartz, Euflexxa, HA, hyaluronic acid

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Triangle Orthopaedic Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Euflexxa

Supartz

Arm Description

Euflexxa® (hyaluronic acid of bacterial origin)

SUPARTZ® (hyaluronic acid of avian origin)

Outcomes

Primary Outcome Measures

WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02110238

First Posted

April 3, 2014

Last Updated

February 12, 2021

Sponsor

Bioventus LLC

Collaborators

Seikagaku Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02110238

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioventus LLC

Collaborators

Seikagaku Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

osteoarthritis, knee pain, Supartz, Euflexxa, HA, hyaluronic acid

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

421 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Euflexxa

Arm Type

Active Comparator

Arm Description

Euflexxa® (hyaluronic acid of bacterial origin)

Arm Title

Supartz

Arm Type

Experimental

Arm Description

SUPARTZ® (hyaluronic acid of avian origin)

Intervention Type

Device

Intervention Name(s)

Supartz

Intervention Description

Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.

Intervention Type

Device

Intervention Name(s)

Euflexxa

Intervention Description

Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.

Primary Outcome Measure Information:

Title

WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline

Description

Time Frame

Change from Baseline (CFB) over Weeks 3, 6, and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vibeke Strand, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Triangle Orthopaedic Associates

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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