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

NCT00131352 | Completed Phase 3 Results

• 1 other identifier: SYNV00704
• Study Type: interventional
• Target: 253
• Locations: 6 countries
• Sites: 21

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.

Conditions

Osteoarthritis, Knee; Musculoskeletal Diseases

Keywords

Osteoarthritis of the knee; Musculoskeletal

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale

  The change from baseline over the course of the 26-week initial treatment period using participants' assessment of pain. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.

  Day 0, up to week 26

Secondary Outcomes (7)

• Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale

  Day 0, Week 26

• Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale

  Week 26

• Change From Baseline Over the Course of the 26-week Initial Treatment Period in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale

  Day 0, up to week 26

• Change From Baseline at Week 26 in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale

  Day 0, Week 26

• Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26

  Week 26

Study Arms (2)

Synvisc

EXPERIMENTAL

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

Device: hylan G-F 20

Saline Control

PLACEBO COMPARATOR

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

Other: Phosphate Buffered Saline

Interventions

hylan G-F 20 DEVICE

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

Also known as: Synvisc-One

Synvisc

Phosphate Buffered Saline OTHER

Single injection of 6 mL phosphate buffered saline.

Saline Control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (21)

Hopital Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Gastuisberg Leuven

Leuven, 3000, Belgium

Location

CHU Liege

Liège, 4000, Belgium

Location

Faculty Hospital Bohunice

Brno, 62500, Czechia

Location

Institute of Rheumatology

Prague, 12850, Czechia

Location

Faculty Thomayer Hospital

Prague, 14059, Czechia

Location

Faculty Hospital Motol

Prague, 15006, Czechia

Location

Hopital Henri Mondor

Créteil, 94010, France

Location

CHU Dupuytren

Limoges, 87042, France

Location

Hopital de la Conception

Marseille, 13005, France

Location

Hopital Rangueil

Toulouse, 31059, France

Location

CHU Hopital Trousseau

Tours, 37044, France

Location

Johanna-Etienne Krankenhaus

Neuss, 41462, Germany

Location

AMC/UVA

Amsterdam, 1100, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

Kings College Hospital

London, SE5 9RJ, United Kingdom

Location

Trafford General Hospital

Manchester, M41 5SL, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Nuffield Orthopaedic Centre

Oxford, OX3 7LD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 19304567 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Genzyme Medical Information
• Organization: Genzyme Corporation

800-745-4447

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 17, 2005
• First Posted: August 18, 2005
• Study Start: May 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: April 3, 2015
• Results First Posted: January 19, 2012

Record last verified: 2015-03

Locations

FR (5); BE (4); DE (1); NL (2); GB (5); CZ (4)