A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee

NCT ID: NCT00131352

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2006-09-30

Brief Summary

This clinical study is to evaluate the safety and efficacy of hylan G-F 20 (Synvisc) in patients with symptomatic knee osteoarthritis (OA). Patients will be given 6 mL of hylan G-F 20 (Synvisc) (or a phosphate buffered saline control), with a possible repeat treatment with Synvisc after the week 26 visit.

Detailed Description

The trial included an initial 26 week treatment with 6 mL of hylan G-F 20 (Synvisc) (or a phosphate buffered saline control) followed by a 4 week repeat treatment of Synvisc.

Conditions

Osteoarthritis, Knee; Musculoskeletal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Synvisc

Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc).

Group Type: EXPERIMENTAL

hylan G-F 20

Intervention Type: DEVICE

Single injection of 6 mL of hylan G-F 20 (Synvisc).

Saline Control

Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.

Group Type: PLACEBO_COMPARATOR

Phosphate Buffered Saline

Intervention Type: OTHER

Single injection of 6 mL phosphate buffered saline.

Interventions

hylan G-F 20

Single injection of 6 mL of hylan G-F 20 (Synvisc).

Intervention Type: DEVICE

Phosphate Buffered Saline

Single injection of 6 mL phosphate buffered saline.

Intervention Type: OTHER

Other Intervention Names

Synvisc-One

Eligibility Criteria

Inclusion Criteria

• Patient with documented diagnosis of primary osteoarthritis (OA) of the target knee made at least 3 months prior to Screening,
• Has radiographic evidence of OA in the tibio-femoral compartment of the target, knee with at least 1 definite osteophyte and a measureable joint space, as diagnosed by standard X-rays taken not longer than 3 months prior to Screening, and before any baseline assessment,
• Has continued target knee pain despite conservative treatment (e.g. weight reduction, physical therapy, analgesics),
• Has pain in the target knee as demonstrated by a score of 2 or 3 on the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale ,
• Has a mean score of 1.5 to 3.5 on the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale.

Exclusion Criteria

• Has modified Kellgren-Lawrence Numerical Grading System of grade IV in the patello-femoral compartment of the target knee confirmed by standard X-rays taken not longer than 3 months prior to Screening, and before any baseline assessment,
• Has clinically apparent tense effusion of the target knee,
• Has had viscosupplementation in any joint including the target knee within 9 months prior to Screening,
• Has concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis and active infection, etc.,)
• Symptomatic OA of the contralateral knee or of either hip that is not responsive to paracetamol and requires other therapy,
• Has related hypersensitivities to avian proteins and/or any components of hyaluronan-based injection devices,

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Genzyme Corporation

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

Hopital Erasme

Brussels, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

Universitair Ziekenhuis Gastuisberg Leuven

Leuven, , Belgium

CHU Liege

Liège, , Belgium

Faculty Hospital Bohunice

Brno, , Czechia

Institute of Rheumatology

Prague, , Czechia

Faculty Thomayer Hospital

Prague, , Czechia

Faculty Hospital Motol

Prague, , Czechia

Hopital Henri Mondor

Créteil, , France

CHU Dupuytren

Limoges, , France

Hopital de la Conception

Marseille, , France

Hopital Rangueil

Toulouse, , France

CHU Hopital Trousseau

Tours, , France

Johanna-Etienne Krankenhaus

Neuss, , Germany

AMC/UVA

Amsterdam, , Netherlands

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

University Hospital of Wales

Cardiff, , United Kingdom

Kings College Hospital

London, , United Kingdom

Trafford General Hospital

Manchester, , United Kingdom

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Nuffield Orthopaedic Centre

Oxford, , United Kingdom

Countries

Belgium; Czechia; France; Germany; Netherlands; United Kingdom

References

Chevalier X, Jerosch J, Goupille P, van Dijk N, Luyten FP, Scott DL, Bailleul F, Pavelka K. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis. 2010 Jan;69(1):113-9. doi: 10.1136/ard.2008.094623.

Reference Type: DERIVED

PMID: 19304567 (View on PubMed)

Other Identifiers

SYNV00704

Identifier Type: -

Identifier Source: org_study_id