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Health Condition(s) or Problem
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Osteoarthritis, Knee; Musculoskeletal Diseases
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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,
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Who cannot enter the trial
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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,
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What will happen
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Device; hylan G-F 20; Single injection of 6 mL of hylan G-F 20 (Synvisc).; Synvisc; Synvisc-One; Other; Phosphate Buffered Saline; Single injection of 6 mL phosphate buffered saline.; Saline Control
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Primary aim
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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
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Secondary Aim
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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; 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; Week 26; 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; Day 0, up to week 26; 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; Day 0, Week 26; 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; Week 26; 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; Week 26; 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; Week 26; 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
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Completed
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Nation
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Wales, England
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Location
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Cardiff, London, Manchester, Newcastle upon Tyne, Oxford
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