A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee
This study has been completed.
Sponsor:
Genzyme
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00131352
First received: August 17, 2005
Last updated: December 15, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis, Knee Musculoskeletal Diseases |
Device: hylan G-F 20 Other: Phosphate Buffered Saline |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-Centre, Parallel, Double-Blind, Blinded Evaluator, Randomised, Placebo-Controlled Evaluation of the Efficacy and Safety of a Single Dose of 6 mL of Synvisc in Patients With Symptomatic Osteoarthritis of the Knee |
Resource links provided by NLM:
Further study details as provided by Genzyme:
Primary Outcome Measures:
- 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 [ Time Frame: Day 0, up to week 26 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- 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 [ Time Frame: Day 0, Week 26 ] [ Designated as safety issue: No ]The change from baseline to week 26 using participants' assessment of pain. The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.
- 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 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]Participants categorized the pain they felt while walking using the WOMAC LK 3.1) A1 (Walking Pain) Subscale. The scale rates pain as none, mild, moderate, severe and extreme.
- 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 [ Time Frame: Day 0, up to week 26 ] [ Designated as safety issue: No ]The change from baseline over the course of the 26-week initial treatment period using participants' assessment of physical function. 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 Function Subscale has a score range of 0-4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.
- 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 [ Time Frame: Day 0, Week 26 ] [ Designated as safety issue: No ]The change from baseline to week 26 using participants' assessment of physical function. The WOMAC Function Subscale has a score range of 0-4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.
- Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]The Participant Global Assessment (PTGA) was used by participants to rate their osteoarthritis (OA). PTGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.
- Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]The Blinded Clinical Observer gave a global assessment (COGA) of the target knee OA. COGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.
- Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Participants were classified as a positive responder if at least one of the following two conditions were met:
- A significant improvement in either the pain (WOMAC A) or physical function (WOMAC C) subscales, defined as both a ≥ 50% improvement from Baseline and an absolute change from Baseline of ≥ 20 normalised units (NU), OR
- Improvement in at least 2 of 3 subscales - pain (WOMAC A), physical function (WOMAC C) or Participant Global Assessment (PTGA). Improvement for all three scales is defined as ≥ 20% improvement from Baseline and an absolute change from Baseline of ≥ 10 NU
| Enrollment: | 253 |
| Study Start Date: | May 2005 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Synvisc
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
Single injection of 6 mL of hylan G-F 20 (Synvisc).
Other Name: Synvisc-One
|
|
Placebo Comparator: Saline Control
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
Single injection of 6 mL phosphate buffered saline.
|
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
- Inclusion Criteria for Repeat Phase: Must have no major safety concerns during the first course of treatment as assessed by the Investigator; Must have a WOMAC LK 3.1 A score of at least 1.
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,
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131352
Locations
| Belgium | |
| Hopital Erasme | |
| Bruxelles, Belgium, 1070 | |
| Universitair Ziekenhuis Gent | |
| Gent, Belgium, 9000 | |
| Universitair Ziekenhuis Gastuisberg Leuven | |
| Leuven, Belgium, 3000 | |
| CHU Liege | |
| Liege, Belgium, 4000 | |
| Czech Republic | |
| Faculty Hospital Bohunice | |
| Brno, Czech Republic, 62500 | |
| Faculty Hospital Motol | |
| Prague, Czech Republic, 15006 | |
| Institute of Rheumatology | |
| Prague 2, Czech Republic, 12850 | |
| Faculty Thomayer Hospital | |
| Prague 4, Czech Republic, 14059 | |
| France | |
| Hopital Henri Mondor | |
| Creteil Cedex, France, 94010 | |
| CHU Dupuytren | |
| Limoges Cedex, France, 87042 | |
| Hopital de la Conception | |
| Marseille, France, 13005 | |
| Hopital Rangueil | |
| Toulouse Cedex 9, France, 31059 | |
| CHU Hopital Trousseau | |
| Tours Cedex, France, 37044 | |
| Germany | |
| Johanna-Etienne Krankenhaus | |
| Neuss, Germany, 41462 | |
| Netherlands | |
| AMC/UVA | |
| Amsterdam, Netherlands, 1100 | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands, 6202 AZ | |
| United Kingdom | |
| University Hospital of Wales | |
| Cardiff, United Kingdom, CF14 4XW | |
| Kings College Hospital | |
| London, United Kingdom, SE5 9RJ | |
| Trafford General Hospital | |
| Manchester, United Kingdom, M41 5SL | |
| Freeman Hospital | |
| Newcastle-upon-Tyne, United Kingdom, NE7 7DN | |
| Nuffield Orthopaedic Centre | |
| Oxford, United Kingdom, OX3 7LD | |
Sponsors and Collaborators
Genzyme
Investigators
| Study Director: | Medical Monitor | Genzyme |
More Information
No publications provided by Genzyme
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medical Monitor, Genzyme Corporation |
| ClinicalTrials.gov Identifier: | NCT00131352 History of Changes |
| Other Study ID Numbers: | SYNV00704 |
| Study First Received: | August 17, 2005 |
| Results First Received: | August 3, 2009 |
| Last Updated: | December 15, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Czech Republic: State Institute for Drug Control Belgium: Federal Agency for Medicinal Products and Health Products Germany: Federal Institute for Drugs and Medical Devices Netherlands: Ministry of Health, Welfare and Sport United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Genzyme:
|
Osteoarthritis of the knee Musculoskeletal |
Additional relevant MeSH terms:
|
Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Rheumatic Diseases |
Hyaluronic Acid Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013