A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee | Completed
A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee
Health Conditions
  • Osteoarthritis, Knee
  • Musculoskeletal Diseases
Completed
Recruitment Status
NCT00131352
Primary Trial ID Number
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.
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; Day 0, up to week 26
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; 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; Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26; Week 26; Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26; Week 26
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
Belgium; Czech Republic; France; Germany; Netherlands; United Kingdom
Participant Sex
Both
Participant Age Range
40 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion 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,
Participant Exclusion 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,
Interventions
Device; hylan G-F 20; Single injection of 6 mL of hylan G-F 20 (Synvisc).; [Synvisc]; Other; Phosphate Buffered Saline; Single injection of 6 mL phosphate buffered saline.; [Saline Control]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific 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
Secondary Trial Identifying Number
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Website
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Study Funded By
Genzyme, a Sanofi Company
Funder Type
Sorry, this information is not available
Study Sponsored By
Genzyme, a Sanofi Company
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

17 Aug 2005

Last Updated

17 Mar 2015

Date Record Refreshed on UKCTG

24 Jul 2015