Clinical trial NCT01618708: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-06-13
Enrollment: 357
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks
timeFrame: From baseline to Week 26
Secondary outcomes:
measure: Change From Baseline in WOMAC A Score Over 26 Weeks
timeFrame: From Baseline to Week 26
measure: Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks
timeFrame: From baseline to Week 26
measure: Percentage of WOMAC A1 Responder Over 26 Weeks
timeFrame: From Baseline to Week 26
Other outcomes:
Locations:
city: Burmingham
country: United States
facility: Investigational Site Number 840025
state: Alabama
city: Phoenix
country: United States
facility: Investigational Site Number 840042
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 840056
state: Arizona
city: Tucson
country: United States
facility: Investigational Site Number 840004
state: Arizona
city: Covina
country: United States
facility: Investigational Site Number 840023
state: California
city: La Mesa
country: United States
facility: Investigational Site Number 840058
state: California
city: Santa Monica
country: United States
facility: Investigational Site Number 840022
state: California
city: Farmington
country: United States
facility: Investigational Site Number 840050
state: Connecticut
city: Stamford
country: United States
facility: Investigational Site Number 840027
state: Connecticut
city: Waterbury
country: United States
facility: Investigational Site Number 840051
state: Connecticut
city: Bradenton
country: United States
facility: Investigational Site Number 840011
state: Florida
city: Fort Lauderdale
country: United States
facility: Investigational Site Number 840036
state: Florida
city: Jupiter
country: United States
facility: Investigational Site Number 840017
state: Florida
city: New Port Richey
country: United States
facility: Investigational Site Number 840038
state: Florida
city: Pensacola
country: United States
facility: Investigational Site Number 840041
state: Florida
city: Sarasota
country: United States
facility: Investigational Site Number 840047
state: Florida
city: South Miami
country: United States
facility: Investigational Site Number 840049
state: Florida
city: Marietta
country: United States
facility: Investigational Site Number 840039
state: Georgia
city: Meridian
country: United States
facility: Investigational Site Number 840005
state: Idaho
city: Chicago
country: United States
facility: Investigational Site Number 840002
state: Illinois
city: Wichita
country: United States
facility: Investigational Site Number 840043
state: Kansas
city: Lexington
country: United States
facility: Investigational Site Number 840012
state: Kentucky
city: Traverse City
country: United States
facility: Investigational Site Number 840033
state: Michigan
city: St. Louis
country: United States
facility: Investigational Site Number 840037
state: Missouri
city: Reno
country: United States
facility: Investigational Site Number 840007
state: Nevada
city: Egg Harbor Township
country: United States
facility: Investigational Site Number 840048
state: New Jersey
city: Amherst
country: United States
facility: Investigational Site Number 840024
state: New York
city: Hartsdale
country: United States
facility: Investigational Site Number 840029
state: New York
city: Rochester
country: United States
facility: Investigational Site Number 840014
state: New York
city: Asheville
country: United States
facility: Investigational Site Number 840044
state: North Carolina
city: Raleigh
country: United States
facility: Investigational Site Number 840028
state: North Carolina
city: Wilmington
country: United States
facility: Investigational Site Number 840045
state: North Carolina
city: Columbus
country: United States
facility: Investigational Site Number 840046
state: Ohio
city: Altoona
country: United States
facility: Investigational Site Number 840013
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Site Number 840055
state: Pennsylvania
city: Reading
country: United States
facility: Investigational Site Number 840018
state: Pennsylvania
city: Mt. Pleasant
country: United States
facility: Investigational Site Number 840026
state: South Carolina
city: Memphis
country: United States
facility: Investigational Site Number 840052
state: Tennessee
city: Austin
country: United States
facility: Investigational Site Number 840054
state: Texas
city: Bedford
country: United States
facility: Investigational Site Number 840040
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840010
state: Texas
city: Draper
country: United States
facility: Investigational Site Number 840009
state: Utah
city: Salt Lake City
country: United States
facility: Investigational Site Number 840032
state: Utah
city: Charlottesville
country: United States
facility: Investigational Site Number 840016
state: Virginia
city: Seattle
country: United States
facility: Investigational Site Number 840003
state: Washington
city: London
country: Canada
facility: Investigational Site Number 124091
city: Montreal
country: Canada
facility: Investigational Site Number 124093
city: Sherbrooke
country: Canada
facility: Investigational Site Number 124092
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: