NCT02110238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
421

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 23, 2016

Completed
Last Updated

March 9, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

April 3, 2014

Results QC Date

March 1, 2016

Last Update Submit

February 12, 2021

Conditions

Osteoarthritis

Keywords

osteoarthritisknee painSupartzEuflexxaHAhyaluronic acid

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Study Arms (2)

Euflexxa

ACTIVE COMPARATOR

Euflexxa® (hyaluronic acid of bacterial origin)

Device: Euflexxa

Supartz

EXPERIMENTAL

SUPARTZ® (hyaluronic acid of avian origin)

Device: Supartz

Interventions

SupartzDEVICE

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

Supartz
EuflexxaDEVICE

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

Euflexxa

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Triangle Orthopaedic Associates

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Junko Takamura
Organization
Seikagaku
junko.takamura@seikagaku.co.jp

Study Officials

  • Vibeke Strand, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 10, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2014

Study Completion

February 1, 2015

Last Updated

March 9, 2021

Results First Posted

June 23, 2016

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)