Study of Safety and Efficacy of 6 mL Synvisc-One (Hylan G-F 20) in Indian Patients With Symptomatic Osteoarthritis of Knee(s) After Initial and Repeat Treatment

NCT ID: NCT02389452

Last Updated: 2017-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 394 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-09-30

Brief Summary

Primary Objective:

To evaluate the safety and efficacy of a single 6 mL intraarticular (IA) injection of Synvisc-One in participants in India with symptomatic osteoarthritis (OA) of the knee(s).

Secondary Objective:

To evaluate the safety and short-term efficacy of a repeat treatment with Synvisc-One.

Detailed Description

A period of approximately 19 months was anticipated from the time the first participants was enrolled in the study to the completion of the study (last participant out). Individual participant participation lasted from 7 to 13 months depending on the timing of repeat treatment.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Synvisc-One

Single 6 mL IA injection of Synvisc-One (48 mg of cross-linked hylan polymer) at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy (no major safety concerns and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore \[measurement of pain while walking on flat surface\] between 40-80 mm, measured on a 0-100 mm scale with 0 represents no pain and 100 represents worst possible pain) at Week 26, 39 or 52 (Repeat treatment).

Group Type: EXPERIMENTAL

Synvisc-One

Intervention Type: DRUG

intraarticular injection

Interventions

Synvisc-One

intraarticular injection

Intervention Type: DRUG

Other Intervention Names

GZ402662; hylan G-F 20

Eligibility Criteria

Inclusion Criteria

• Male and female participant aged 30 years or older, with active lifestyle.
• The participant must be able to read, understand, and sign an informed consent form, understand requirements for followup visits, and must be willing to provide information at the scheduled evaluations.
• The participant had a diagnosis of OA of the target knee confirmed by recent X-ray (mild to moderate joint space narrowing and/or osteophytes (ie, Kellgren Lawrence [KL] Grade I-III), predominant in the tibiofemoral compartment.
• WOMAC A1 baseline 100 mm visual analog scale (VAS) score from 40-80 mm (moderate or severe walking pain) in the target knee.
• Participants with bilateral disease may be included in the study with the below strict conditions:

• If female, must had a negative urine pregnancy test and continue to use a medically acceptable form of contraception for the duration of the study. Otherwise, females must had been surgically sterile or postmenopausal (as documented in the medical history) for at least 1 year.

Exclusion Criteria

• Significant (requiring surgical correction) valgus or varus deformity of the knee, ligamentous laxity, or meniscal instability.
• Concomitant inflammatory or any other disease/condition which may affect joints (eg, rheumatoid arthritis, metabolic bone disease, psoriasis, gout, pseudogout, or chondrocalcinosis).
• History of sepsis in any joint or any clinical concern for a subacute infectious process in the target joint.
• History of surgery in the target knee.
• Planned surgery on any lower extremity joint.
• Clinically significant venous or lymphatic stasis present in the leg(s).
• Clinically apparent tense effusion or inflammation at the target knee.
• Skin disease or infection in the area of the injection site.
• Any musculoskeletal condition that would impede measurement of efficacy at the target knee.
• Pregnant or lactating women.
• Hypersensitivities to avian proteins and/or any components of hyaluronan-based injection.
• Treatment with any hyaluronic acid (HA) or derivatives in the previous 6 months.
• Treatment with IA steroids in the previous 3 months.
• Any contraindication to IA injection, eg, anticoagulant therapy or clinical concern for potential coagulopathy (eg, liver disease).
• Any significant medical condition (eg, significant psychiatric or neurological disorders or active alcohol/drug abuse), any medical condition that is unstable/poorly controlled or other factors (eg, planned relocation) that the Investigator felt would interfere with study evaluations and study participation.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

U1111-1167-6813

Identifier Type: OTHER

Identifier Source: secondary_id

SYNV03809

Identifier Type: -

Identifier Source: org_study_id