A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip

May 31, 2016 updated by: Genzyme, a Sanofi Company

A Pivotal, Multicenter, Double Blind Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Mild to Moderate Primary Osteoarthritis of the Hip

The primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, Canada, N6C 4R3
        • Investigational Site Number 124091
      • Montreal, Canada, H4N 3C5
        • Investigational Site Number 124093
      • Sherbrooke, Canada, J1H 1Z1
        • Investigational Site Number 124092
    • Alabama
      • Burmingham, Alabama, United States, 35216
        • Investigational Site Number 840025
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Investigational Site Number 840042
      • Phoenix, Arizona, United States, 85027
        • Investigational Site Number 840056
      • Tucson, Arizona, United States, 85712
        • Investigational Site Number 840004
    • California
      • Covina, California, United States, 91723
        • Investigational Site Number 840023
      • La Mesa, California, United States, 91942
        • Investigational Site Number 840058
      • Santa Monica, California, United States, 90904
        • Investigational Site Number 840022
    • Connecticut
      • Farmington, Connecticut, United States, 06033
        • Investigational Site Number 840050
      • Stamford, Connecticut, United States, 06905
        • Investigational Site Number 840027
      • Waterbury, Connecticut, United States, 06708
        • Investigational Site Number 840051
    • Florida
      • Bradenton, Florida, United States, 84020
        • Investigational Site Number 840011
      • Fort Lauderdale, Florida, United States, 33316
        • Investigational Site Number 840036
      • Jupiter, Florida, United States, 33458
        • Investigational Site Number 840017
      • New Port Richey, Florida, United States, 34652
        • Investigational Site Number 840038
      • Pensacola, Florida, United States, 32504
        • Investigational Site Number 840041
      • Sarasota, Florida, United States, 34232
        • Investigational Site Number 840047
      • South Miami, Florida, United States, 33134
        • Investigational Site Number 840049
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Investigational Site Number 840039
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Investigational Site Number 840005
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Investigational Site Number 840002
    • Kansas
      • Wichita, Kansas, United States, 67203
        • Investigational Site Number 840043
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Investigational Site Number 840012
    • Michigan
      • Traverse City, Michigan, United States, 49648
        • Investigational Site Number 840033
    • Missouri
      • St. Louis, Missouri, United States, 63128
        • Investigational Site Number 840037
    • Nevada
      • Reno, Nevada, United States, 89502
        • Investigational Site Number 840007
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Investigational Site Number 840048
    • New York
      • Amherst, New York, United States, 14226
        • Investigational Site Number 840024
      • Hartsdale, New York, United States, 10530
        • Investigational Site Number 840029
      • Rochester, New York, United States, 14609
        • Investigational Site Number 840014
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Investigational Site Number 840044
      • Raleigh, North Carolina, United States, 27612
        • Investigational Site Number 840028
      • Wilmington, North Carolina, United States, 28401
        • Investigational Site Number 840045
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Investigational Site Number 840046
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16635
        • Investigational Site Number 840013
      • Philadelphia, Pennsylvania, United States, 19107
        • Investigational Site Number 840055
      • Reading, Pennsylvania, United States, 19611
        • Investigational Site Number 840018
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Investigational Site Number 840026
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Investigational Site Number 840052
    • Texas
      • Austin, Texas, United States, 78751
        • Investigational Site Number 840054
      • Bedford, Texas, United States, 76021
        • Investigational Site Number 840040
      • Dallas, Texas, United States, 75235
        • Investigational Site Number 840010
    • Utah
      • Draper, Utah, United States, 84020
        • Investigational Site Number 840009
      • Salt Lake City, Utah, United States, 84107
        • Investigational Site Number 840032
    • Virginia
      • Charlottesville, Virginia, United States, 22901
        • Investigational Site Number 840016
    • Washington
      • Seattle, Washington, United States, 98166
        • Investigational Site Number 840003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The participant had symptomatic osteoarthritis (OA) in the target joint
  • The participant had a diagnosis of primary OA of the hip at Screening according to the American College of Rheumatology (ACR) Criteria
  • The participant, if female and of childbearing potential, must had a negative pregnancy test and had taken oral contraceptives for at least 1 month prior to treatment and continued for the duration of the study (up to and including the final study visit), or agreed to use 2 forms of contraception (e.g., condoms plus spermatocide), otherwise females must be surgically sterile, or postmenopausal for at least 1 year

Exclusion Criteria:

  • The participant had symptomatic OA in the contralateral hip with a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 numerical rating scale (NRS) score of ≥ 4 at Screening (symptomatic OA with a WOMAC A1 NRS score of 0-3 in the contralateral hip was allowed)
  • The participant if a woman was pregnant, lactating, or unwilling to use adequate contraception
  • The participant had prior viscosupplementation therapy in the target hip joint within 26 weeks of Screening
  • The participant had a known history of hypersensitivity to avian protein or any components of hyaluronan-based injection devices
  • The participant had a known history of hypersensitivity to steroids, lidocaine, and/or acetaminophen
  • The participant had a known history of hypersensitivity to injected contrast agent at a previous radiological examination (e.g., computed tomography [CT] scan, angiogram, etc.), or known history of hypersensitivity to shellfish or iodine, or any other impediment to the hip injection procedure
  • The participant had active infection in the area of the injection site
  • The participant had any major surgery, arthroplasty or arthroscopy in the target hip or lower extremities within 26 weeks of Screening, or planned surgery in the lower extremities throughout the duration of the study infectious complications
  • The participant used an investigational drug, device or biologic within 12 weeks of Screening
  • The participant had any significant medical condition that the Investigator feels would interfere with study evaluations and study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Synvisc-One
Single intraarticular (IA) injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
6-mL IA injection
Placebo Comparator: Placebo
Single IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period.
6 mL injection of phosphate buffered saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks
Time Frame: From baseline to Week 26
WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.
From baseline to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in WOMAC A Score Over 26 Weeks
Time Frame: From Baseline to Week 26
WOMAC NRS 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) was measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.
From Baseline to Week 26
Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks
Time Frame: From baseline to Week 26
PTGA (self-assessment of target hip osteoarthritis condition) was measured using the 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents very well condition and higher score represents very poor condition.
From baseline to Week 26
Percentage of WOMAC A1 Responder Over 26 Weeks
Time Frame: From Baseline to Week 26
WOMAC A1 responder rate defined as ≥2 point improvement on 11-point NRS Scale, generalized estimating equations modeling was used for the analysis of WOMAC A1 responders.
From Baseline to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 13, 2012

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • SYNV04910
  • EFC12791 (Other Identifier: Sanofi)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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