Status:
COMPLETED
A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Osteoarthritis, Knee
Musculoskeletal Diseases
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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 ...
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 Criteria
Inclusion
- 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,
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT00131352
Start Date
May 1 2005
End Date
September 1 2006
Last Update
April 3 2015
Active Locations (21)
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1
Hopital Erasme
Brussels, Belgium, 1070
2
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
3
Universitair Ziekenhuis Gastuisberg Leuven
Leuven, Belgium, 3000
4
CHU Liege
Liège, Belgium, 4000