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

Recruiting in Palo Alto (17 mi)

+47 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Genzyme, a Sanofi Company

Trial Summary

What is the purpose of this trial?

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

Research Team

Medical Monitor

Principal Investigator

Genzyme, a Sanofi Company

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

Treatment Details

Interventions

Placebo (Procedure)
Synvisc-One (hylan G-F 20) (Viscosupplementation)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Synvisc-OneExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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