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

Genzyme

Status: Completed

Conditions: Osteoarthritis, Hip

Treatments: Device: Synvisc-One (hylan G-F 20); Device: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01618708

EFC12791 (Other Identifier)

SYNV04910

Details and patient eligibility

About

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

Enrollment: 357 patients

Sex: All

Ages: 35+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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357 participants in 2 patient groups, including a placebo group

Synvisc-One

Experimental group

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.

Treatment:

Device: Synvisc-One (hylan G-F 20)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo