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

Primary Purpose

Osteoarthritis, Hip

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Synvisc-One (hylan G-F 20)
Placebo
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational Site Number 840025
  • Investigational Site Number 840042
  • Investigational Site Number 840056
  • Investigational Site Number 840004
  • Investigational Site Number 840023
  • Investigational Site Number 840058
  • Investigational Site Number 840022
  • Investigational Site Number 840050
  • Investigational Site Number 840027
  • Investigational Site Number 840051
  • Investigational Site Number 840011
  • Investigational Site Number 840036
  • Investigational Site Number 840017
  • Investigational Site Number 840038
  • Investigational Site Number 840041
  • Investigational Site Number 840047
  • Investigational Site Number 840049
  • Investigational Site Number 840039
  • Investigational Site Number 840005
  • Investigational Site Number 840002
  • Investigational Site Number 840043
  • Investigational Site Number 840012
  • Investigational Site Number 840033
  • Investigational Site Number 840037
  • Investigational Site Number 840007
  • Investigational Site Number 840048
  • Investigational Site Number 840024
  • Investigational Site Number 840029
  • Investigational Site Number 840014
  • Investigational Site Number 840044
  • Investigational Site Number 840028
  • Investigational Site Number 840045
  • Investigational Site Number 840046
  • Investigational Site Number 840013
  • Investigational Site Number 840055
  • Investigational Site Number 840018
  • Investigational Site Number 840026
  • Investigational Site Number 840052
  • Investigational Site Number 840054
  • Investigational Site Number 840040
  • Investigational Site Number 840010
  • Investigational Site Number 840009
  • Investigational Site Number 840032
  • Investigational Site Number 840016
  • Investigational Site Number 840003
  • Investigational Site Number 124091
  • Investigational Site Number 124093
  • Investigational Site Number 124092

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Synvisc-One

Placebo

Arm Description

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.

Single IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period.

Outcomes

Primary Outcome Measures

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks
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.

Secondary Outcome Measures

Change From Baseline in WOMAC A Score Over 26 Weeks
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.
Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks
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.
Percentage of WOMAC A1 Responder Over 26 Weeks
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.

Full Information

First Posted
June 11, 2012
Last Updated
May 31, 2016
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01618708
Brief Title
A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Synvisc-One
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period.
Intervention Type
Device
Intervention Name(s)
Synvisc-One (hylan G-F 20)
Intervention Description
6-mL IA injection
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
6 mL injection of phosphate buffered saline
Primary Outcome Measure Information:
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks
Description
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.
Time Frame
From baseline to Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in WOMAC A Score Over 26 Weeks
Description
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.
Time Frame
From Baseline to Week 26
Title
Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks
Description
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.
Time Frame
From baseline to Week 26
Title
Percentage of WOMAC A1 Responder Over 26 Weeks
Description
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.
Time Frame
From Baseline to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840025
City
Burmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Investigational Site Number 840042
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Investigational Site Number 840056
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Investigational Site Number 840004
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Investigational Site Number 840023
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Investigational Site Number 840058
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Investigational Site Number 840022
City
Santa Monica
State/Province
California
ZIP/Postal Code
90904
Country
United States
Facility Name
Investigational Site Number 840050
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06033
Country
United States
Facility Name
Investigational Site Number 840027
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Investigational Site Number 840051
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Investigational Site Number 840011
City
Bradenton
State/Province
Florida
ZIP/Postal Code
84020
Country
United States
Facility Name
Investigational Site Number 840036
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Investigational Site Number 840017
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Investigational Site Number 840038
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Investigational Site Number 840041
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Investigational Site Number 840047
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Investigational Site Number 840049
City
South Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Investigational Site Number 840039
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Investigational Site Number 840005
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Investigational Site Number 840002
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Investigational Site Number 840043
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Investigational Site Number 840012
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Investigational Site Number 840033
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49648
Country
United States
Facility Name
Investigational Site Number 840037
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Investigational Site Number 840007
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Investigational Site Number 840048
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Investigational Site Number 840024
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Investigational Site Number 840029
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Investigational Site Number 840014
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Investigational Site Number 840044
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Investigational Site Number 840028
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Investigational Site Number 840045
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Investigational Site Number 840046
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Investigational Site Number 840013
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Investigational Site Number 840055
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Investigational Site Number 840018
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Investigational Site Number 840026
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Investigational Site Number 840052
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Investigational Site Number 840054
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Investigational Site Number 840040
City
Bedford
State/Province
Texas
ZIP/Postal Code
76021
Country
United States
Facility Name
Investigational Site Number 840010
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Investigational Site Number 840009
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Investigational Site Number 840032
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Investigational Site Number 840016
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22901
Country
United States
Facility Name
Investigational Site Number 840003
City
Seattle
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Investigational Site Number 124091
City
London
ZIP/Postal Code
N6C 4R3
Country
Canada
Facility Name
Investigational Site Number 124093
City
Montreal
ZIP/Postal Code
H4N 3C5
Country
Canada
Facility Name
Investigational Site Number 124092
City
Sherbrooke
ZIP/Postal Code
J1H 1Z1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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