A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip
NCT ID: NCT01618708
Last Updated: 2016-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
357 participants
INTERVENTIONAL
2012-09-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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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.
Synvisc-One (hylan G-F 20)
6-mL IA injection
Placebo
Single IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period.
Placebo
6 mL injection of phosphate buffered saline
Interventions
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Synvisc-One (hylan G-F 20)
6-mL IA injection
Placebo
6 mL injection of phosphate buffered saline
Eligibility Criteria
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Inclusion Criteria
* 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 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
35 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Investigational Site Number 124093
Montreal, , Canada
Investigational Site Number 124092
Sherbrooke, , Canada
Investigational Site Number 840025
Burmingham, Alabama, United States
Investigational Site Number 840042
Phoenix, Arizona, United States
Investigational Site Number 840056
Phoenix, Arizona, United States
Investigational Site Number 840004
Tucson, Arizona, United States
Investigational Site Number 840023
Covina, California, United States
Investigational Site Number 840058
La Mesa, California, United States
Investigational Site Number 840022
Santa Monica, California, United States
Investigational Site Number 840050
Farmington, Connecticut, United States
Investigational Site Number 840027
Stamford, Connecticut, United States
Investigational Site Number 840051
Waterbury, Connecticut, United States
Investigational Site Number 840011
Bradenton, Florida, United States
Investigational Site Number 840036
Fort Lauderdale, Florida, United States
Investigational Site Number 840017
Jupiter, Florida, United States
Investigational Site Number 840038
New Port Richey, Florida, United States
Investigational Site Number 840041
Pensacola, Florida, United States
Investigational Site Number 840047
Sarasota, Florida, United States
Investigational Site Number 840049
South Miami, Florida, United States
Investigational Site Number 840039
Marietta, Georgia, United States
Investigational Site Number 840005
Meridian, Idaho, United States
Investigational Site Number 840002
Chicago, Illinois, United States
Investigational Site Number 840043
Wichita, Kansas, United States
Investigational Site Number 840012
Lexington, Kentucky, United States
Investigational Site Number 840033
Traverse City, Michigan, United States
Investigational Site Number 840037
St Louis, Missouri, United States
Investigational Site Number 840007
Reno, Nevada, United States
Investigational Site Number 840048
Egg Harbor, New Jersey, United States
Investigational Site Number 840024
Amherst, New York, United States
Investigational Site Number 840029
Hartsdale, New York, United States
Investigational Site Number 840014
Rochester, New York, United States
Investigational Site Number 840044
Asheville, North Carolina, United States
Investigational Site Number 840028
Raleigh, North Carolina, United States
Investigational Site Number 840045
Wilmington, North Carolina, United States
Investigational Site Number 840046
Columbus, Ohio, United States
Investigational Site Number 840013
Altoona, Pennsylvania, United States
Investigational Site Number 840055
Philadelphia, Pennsylvania, United States
Investigational Site Number 840018
Reading, Pennsylvania, United States
Investigational Site Number 840026
Mt. Pleasant, South Carolina, United States
Investigational Site Number 840052
Memphis, Tennessee, United States
Investigational Site Number 840054
Austin, Texas, United States
Investigational Site Number 840040
Bedford, Texas, United States
Investigational Site Number 840010
Dallas, Texas, United States
Investigational Site Number 840009
Draper, Utah, United States
Investigational Site Number 840032
Salt Lake City, Utah, United States
Investigational Site Number 840016
Charlottesville, Virginia, United States
Investigational Site Number 840003
Seattle, Washington, United States
Investigational Site Number 124091
London, , Canada
Countries
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Other Identifiers
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EFC12791
Identifier Type: OTHER
Identifier Source: secondary_id
SYNV04910
Identifier Type: -
Identifier Source: org_study_id
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