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

Completed · Not applicable · Has a placebo group

Conditions studied: Osteoarthritis, Hip

In brief

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

Key facts

Study ID

NCT01618708

Run by

Genzyme, a Sanofi Company

People needed

357

Starts

2012-09-01

Expected to finish

2015-06-01

Last updated by the study team

2016-07-11

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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