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

Osteoarthritis, Hip Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618708
• Other study ID #: SYNV04910
• Secondary ID: EFC12791
• Status: Completed
• Phase: N/A
• First received: June 11, 2012
• Last updated: August 3, 2015
• Start date: September 2012
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• The patient has symptomatic OA in the target joint

• The patient has had a diagnosis of primary OA of the hip at Screening according to the American College of Rheumatology (ACR) Criteria

• The patient, if female and of childbearing potential, must have a negative pregnancy test and have taken oral contraceptives for at least 1 month prior to treatment and continue for the duration of the study (up to and including the final study visit), or agree 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 patient has symptomatic OA in the contralateral hip with a WOMAC A1 NRS score of = 4 at Screening (symptomatic OA with a WOMAC A1 NRS score of 0-3 in the contralateral hip is allowed)

• The patient if a woman is pregnant, lactating, or unwilling to use adequate contraception

• The patient had prior viscosupplementation therapy in the target hip joint within 26 weeks of Screening

• The patient has a known history of hypersensitivity to avian protein or any components of hyaluronan-based injection devices

• The patient has a known history of hypersensitivity to steroids, lidocaine, and/or acetaminophen

• The patient has 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 patient has active infection in the area of the injection site

• The patient has 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 patient used an investigational drug, device or biologic within 12 weeks of Screening

• The patient has any significant medical condition that the Investigator feels would interfere with study evaluations and study participation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• Synvisc-One (hylan G-F 20)
6-mL intra-articular (IA) injection
• Saline Placebo
6 mL injection of phosphate buffered saline

Locations

Country	Name	City	State
Canada	Investigational Site Number 124091	London
Canada	Investigational Site Number 124093	Montreal
Canada	Investigational Site Number 124092	Sherbrooke
United States	Investigational Site Number 840013	Altoona	Pennsylvania
United States	Investigational Site Number 840024	Amherst	New York
United States	Investigational Site Number 840044	Asheville	North Carolina
United States	Investigational Site Number 840054	Austin	Texas
United States	Investigational Site Number 840040	Bedford	Texas
United States	Investigational Site Number 840011	Bradenton	Florida
United States	Investigational Site Number 840025	Burmingham	Alabama
United States	Investigational Site Number 840016	Charlottesville	Virginia
United States	Investigational Site Number 840002	Chicago	Illinois
United States	Investigational Site Number 840046	Columbus	Ohio
United States	Investigational Site Number 840023	Covina	California
United States	Investigational Site Number 840010	Dallas	Texas
United States	Investigational Site Number 840009	Draper	Utah
United States	Investigational Site Number 840048	Egg Harbor Township	New Jersey
United States	Investigational Site Number 840050	Farmington	Connecticut
United States	Investigational Site Number 840036	Fort Lauderdale	Florida
United States	Investigational Site Number 840029	Hartsdale	New York
United States	Investigational Site Number 840017	Jupiter	Florida
United States	Investigational Site Number 840058	La Mesa	California
United States	Investigational Site Number 840012	Lexington	Kentucky
United States	Investigational Site Number 840039	Marietta	Georgia
United States	Investigational Site Number 840052	Memphis	Tennessee
United States	Investigational Site Number 840005	Meridian	Idaho
United States	Investigational Site Number 840026	Mt. Pleasant	South Carolina
United States	Investigational Site Number 840038	New Port Richey	Florida
United States	Investigational Site Number 840041	Pensacola	Florida
United States	Investigational Site Number 840055	Philadelphia	Pennsylvania
United States	Investigational Site Number 840042	Phoenix	Arizona
United States	Investigational Site Number 840056	Phoenix	Arizona
United States	Investigational Site Number 840028	Raleigh	North Carolina
United States	Investigational Site Number 840018	Reading	Pennsylvania
United States	Investigational Site Number 840007	Reno	Nevada
United States	Investigational Site Number 840014	Rochester	New York
United States	Investigational Site Number 840032	Salt Lake City	Utah
United States	Investigational Site Number 840022	Santa Monica	California
United States	Investigational Site Number 840047	Sarasota	Florida
United States	Investigational Site Number 840003	Seattle	Washington
United States	Investigational Site Number 840049	South Miami	Florida
United States	Investigational Site Number 840037	St. Louis	Missouri
United States	Investigational Site Number 840027	Stamford	Connecticut
United States	Investigational Site Number 840033	Traverse City	Michigan
United States	Investigational Site Number 840004	Tucson	Arizona
United States	Investigational Site Number 840051	Waterbury	Connecticut
United States	Investigational Site Number 840043	Wichita	Kansas
United States	Investigational Site Number 840045	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline using the patient's assessment of his/her walking pain (WOMAC A1)		26 weeks	No
Secondary	Change from Baseline in WOMAC A		26 weeks	No
Secondary	Change from Baseline in Patient Global Self-Assessment (PTGA) of target hip osteoarthritis (OA)		26 weeks	No
Secondary	WOMAC A1 responder rate		26 weeks	No
Secondary	Number of patients reporting treatment-emergent adverse events (AEs)		26 weeks	Yes