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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
357

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
      • London, Canada, N6C 4R3
        • Investigational Site Number 124091
      • Montreal, Canada, H4N 3C5
        • Investigational Site Number 124093
      • Sherbrooke, Canada, J1H 1Z1
        • Investigational Site Number 124092
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Synvisc-One (hylan G-F 20)
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.
Device: Placebo
6 mL injection of phosphate buffered saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genzyme, a Sanofi Company

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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