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

Genzyme, a Sanofi Company48 sites in 2 countries357 target enrollmentSeptember 2012

ConditionsOsteoarthritis, Hip

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis, Hip
Sponsor: Genzyme, a Sanofi Company
Enrollment: 357
Locations: 48
Primary Endpoint: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

June 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genzyme, a Sanofi Company

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks

Time Frame: From baseline to Week 26

WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.

Secondary Outcomes

Change From Baseline in WOMAC A Score Over 26 Weeks(From Baseline to Week 26)
Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks(From baseline to Week 26)
Percentage of WOMAC A1 Responder Over 26 Weeks(From Baseline to Week 26)