NCT01295580

Brief Summary

The purpose of this study is to determine the comparative safety and efficacy of intra-articular injection of hyaluronic acid, obtained from two different sources, in the treatment of osteoarthritic pain of the knee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
349

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

7 active sites

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

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

April 9, 2021

Completed
Last Updated

April 9, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

February 11, 2011

Results QC Date

November 7, 2017

Last Update Submit

March 16, 2021

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • WOMAC (Western Ontario and McMaster Osteoarthritis Index) Pain Subscale Change From Baseline

    Pain assessment is made of 5 items; each has 5 possible values 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The items are summed for a total range of 0 to 20. Therefore, the pain change from baseline range is -20 to 20. A negative change is a reduction in pain from the baseline pain score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame".

    over 18 weeks (week timepoints 6, 10, 14, and 18)

Secondary Outcomes (7)

  • WOMAC (Western Ontario and McMaster Osteoarthritis Index) Pain Subscale Change From Baseline

    over 26 weeks (week 6, 10, 14, 18, and 26)

  • WOMAC (Western Ontario and McMaster Osteoarthritis Index) Physical Function Subscale Change From Baseline

    over 18 weeks (week timepoints 6, 10, 14, and 18)

  • WOMAC (Western Ontario and McMaster Osteoarthritis Index) Physical Function Subscale Change From Baseline

    over 26 weeks (week timepoints 6, 10, 14, 18, and 26)

  • Subject Global Assessment Change From Baseline

    over 18 weeks (week timepoints 6, 10, 14, and 18)

  • Subject Global Assessment Change From Baseline

    over 26 weeks (week timepoints 6, 10, 14, 18, and 26)

  • +2 more secondary outcomes

Study Arms (2)

ARTZ sodium hyaluronate

ACTIVE COMPARATOR

The comparator product, ARTZ, is manufactured by Seikagaku Corporation, Japan. Subjects randomized to the ARTZ group were administered five weekly intra-articular injections (2.5 ml, NASHA 25 mg). ARTZ is a sterile, viscoelastic nonpyrogenic solution of purified, high molecular weight (620,000-1,170,000 daltons) sodium hyaluronate having a pH of 6.8-7.8. The sodium hyaluronate is extracted from chicken combs.

Device: ARTZ

DUROLANE hyaluronic acid

ACTIVE COMPARATOR

The investigational product was provided in pre-filled syringes containing stabilized non-animal hyaluronic acid (20 mg/mL). Only one injection was given for those subjects randomized to the DUROLANE group, followed by 4 sham injections. DUROLANE is free from products of animal origin and is manufactured by Q-Med AB Corporation.The sham injection procedure was same as the active injection, except that they were subcutaneous and an empty syringe was used.

Device: DUROLANE

Interventions

ARTZDEVICE

Hyaluronic acid (five 2.5 mL injections)

ARTZ sodium hyaluronate
DUROLANEDEVICE

Hyaluronic acid stabilized (one 3.0 mL injection + four weekly 0 mL sham injections)

DUROLANE hyaluronic acid

Eligibility Criteria

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

You may qualify if:

  • Subject (female or male) 40-80 years of age, inclusive
  • Documented diagnosis of mild to moderate osteoarthritis of the study knee that fulfil the ACR(American College of Rheumatology) criteria
  • Radiographic evidence of osteoarthritis in the study knee (Kellgren Lawrence radiographic score is 2 or 3)

You may not qualify if:

  • Clinically apparent tense effusion of the study knee on examination determined by either a positive bulge sign or positive ballottement of the patella
  • Kellgren-Lawrence radiographic score 0, 1 or 4 in the study knee
  • Symptomatic osteoarthritis of the contralateral knee or of either hip that is not responsive to acetaminophen/paracetamol and/or requires any protocol prohibited therapies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Beijing Frienship Hospital

Beijing, China

Location

Beijing General Military Hospital

Beijing, China

Location

Beijing University #3 Hospital

Beijing, China

Location

Beijing University People's Hospital

Beijing, China

Location

Zhejiang #2 Hospital

Hangzhou, China

Location

Shanghai #6 People's Hospital

Shanghai, China

Location

Shanghai #9 People's Hospital

Shanghai, China

Location

Related Publications (1)

  • Zhang H, Zhang K, Zhang X, Zhu Z, Yan S, Sun T, Guo A, Jones J, Steen RG, Shan B, Zhang J, Lin J. Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE) study in knee osteoarthritis: a multicenter, randomized, double-blind, 26-week non-inferiority trial comparing Durolane to Artz. Arthritis Res Ther. 2015 Mar 10;17(1):51. doi: 10.1186/s13075-015-0557-x.

    PMID: 25889322RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Director, Regulatory and Clinical Affairs
Organization
Bioventus, LLC
1-800-396-4325

Study Officials

  • Jianhao Lin, MD

    People Hospital of Beijing University No. 11 South Ave., Xizhimen, Beijing

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigational product was masked from study staff and participants with the exception of the unblinded treating investigator conducting the intra-articular injections.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 14, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2011

Study Completion

February 1, 2012

Last Updated

April 9, 2021

Results First Posted

April 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)