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Effectiveness and Safety of Synvisc® Versus Usual Treatments in Patients With Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Hylan G-F 20
Standard treatment
Physiotherapy
Hydrotherapy
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female outpatient aged at least 18 years
  • Patient suffering from predominant femoro-tibial knee osteoarthrosis with or without effusion. The diagnosis must be based on American College of Rheumatology (ACR) criteria. Radiological grade will be assess according to Kellgren-Lawrence scale
  • Assessment of pain on active movement (i.e. walking) (by the patient) must be at least 40 mm on a 100 mm VAS
  • Patient who received at least two courses of at least ten days within the last three months with non-steroidal antiinflammatory drugs (NSAID) and/or who are treated continuously for the last two month with slow-acting anti-osteoarthritis drugs
  • Patient's informed written consent obtained in accordance with French legislation

Exclusion Criteria:

  • Patient suffering from acute congestive osteoarthritis flare of the target knee (at the time of inclusion) which means that concomitantly to knee effusion at least 2 of the following criteria are present:

    • nocturnal disturbances due to knee pain
    • morning stiffness over 45 minutes
    • increase of knee pain more than 50% within the last week
    • articular reddening
    • articular heat
  • Intra-articular administration of hyaluronic acid in the target knee within the previous year
  • Intra-articular administration of hyaluronic acid in the target knee within the three previous months
  • Any other intra-articular injection in the target knee within the last 6 months
  • Any contraindication to intra-articular injections
  • Present or past history of infected target knee joint
  • Previous prosthesis knee surgery, tibial osteotomy, synovectomy or synoviorthese of the target knee
  • Arthroscopy, articular lavage, debridement, menisectomy of the target knee within the previous year
  • Planned knee surgery within the nine following month
  • Any other musculoskeletal disorders that can interfere with osteoarthritis diagnosis or the evaluation of its severity
  • Known hypersensitivity to avian products
  • Presence of lymphatic or venous stasis
  • Pregnancy or breastfeeding
  • Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, haematological disease, mental disturbance
  • Participation in another clinical trial during this study or during the previous month
  • Previous participation in this trial
  • Patient who requires help concerning shopping or house keeping
  • Patient unable to comply with the protocol (e.g. patient unable to attend each trial visit or to fill the diary booklet or the quality of life questionnaire)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Synvisc group

    Osteoarthritis standard treatment group

    Arm Description

    injection of Synvisc® at day 1, day 8 and day 15; in the mean time it will be recommended to decrease or stop all other OA treatments

    Treatment will be left to the discretion of the investigator who could prescribe any therapies, except viscosupplementation product

    Outcomes

    Primary Outcome Measures

    Cost of knee OA treatment including cost of side effect related to OA treatment
    Area under the curve (AUC) Lequesne index
    Index of severity

    Secondary Outcome Measures

    Assessment of Western Ontario and McMaster Universities (WOMAC) index by patient
    Patient's assessment of pain on movement and rest on a visual analogue scale (VAS) through WOMAC question 1 and 3
    Disease activity assessment by patient and investigator on a VAS
    Acute congestive OA flares assessed through a questionnaire
    Assessment of state of health of the patients with a quality of life questionnaire (SF 12)
    Final global assessment of efficacy by patient and investigator on a four-point verbal rating scale (VRS)
    Final global assessment of tolerability by patient and investigator on a four-point VRS
    Incidence and intensity of adverse events
    Number of withdrawals due to adverse event

    Full Information

    First Posted
    July 18, 2014
    Last Updated
    July 21, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02197026
    Brief Title
    Effectiveness and Safety of Synvisc® Versus Usual Treatments in Patients With Knee Osteoarthritis
    Official Title
    A Multicentre, Open-label and Randomized Clinical Trial to Compare in Patient With Knee Osteoarthritis the Medicoeconomic Benefits as Well as Effectiveness and Safety of Synvisc® Versus Usual Treatments.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1998 (undefined)
    Primary Completion Date
    February 2000 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    Brief Summary
    Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc® versus usual treatments as well as evaluation of safety and effectiveness of these treatments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    518 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Synvisc group
    Arm Type
    Experimental
    Arm Description
    injection of Synvisc® at day 1, day 8 and day 15; in the mean time it will be recommended to decrease or stop all other OA treatments
    Arm Title
    Osteoarthritis standard treatment group
    Arm Type
    Active Comparator
    Arm Description
    Treatment will be left to the discretion of the investigator who could prescribe any therapies, except viscosupplementation product
    Intervention Type
    Drug
    Intervention Name(s)
    Hylan G-F 20
    Other Intervention Name(s)
    Synvisc®
    Intervention Type
    Drug
    Intervention Name(s)
    Standard treatment
    Intervention Description
    Standard drug treatment at the discretion of the investigator
    Intervention Type
    Procedure
    Intervention Name(s)
    Physiotherapy
    Intervention Type
    Procedure
    Intervention Name(s)
    Hydrotherapy
    Primary Outcome Measure Information:
    Title
    Cost of knee OA treatment including cost of side effect related to OA treatment
    Time Frame
    up to 274 days
    Title
    Area under the curve (AUC) Lequesne index
    Description
    Index of severity
    Time Frame
    Day 1, 29, 91, 182 and 274
    Secondary Outcome Measure Information:
    Title
    Assessment of Western Ontario and McMaster Universities (WOMAC) index by patient
    Time Frame
    Day 1, 91, 182 and 274
    Title
    Patient's assessment of pain on movement and rest on a visual analogue scale (VAS) through WOMAC question 1 and 3
    Time Frame
    Day 1, 91, 182 and 274
    Title
    Disease activity assessment by patient and investigator on a VAS
    Time Frame
    Day 1, 29, 91, 182 and 274
    Title
    Acute congestive OA flares assessed through a questionnaire
    Time Frame
    Day 1, 29, 91, 182 and 274
    Title
    Assessment of state of health of the patients with a quality of life questionnaire (SF 12)
    Time Frame
    Day 1, 91, 182, 274
    Title
    Final global assessment of efficacy by patient and investigator on a four-point verbal rating scale (VRS)
    Time Frame
    Day 274
    Title
    Final global assessment of tolerability by patient and investigator on a four-point VRS
    Time Frame
    Day 274
    Title
    Incidence and intensity of adverse events
    Time Frame
    up to day 274
    Title
    Number of withdrawals due to adverse event
    Time Frame
    up to day 274

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female outpatient aged at least 18 years Patient suffering from predominant femoro-tibial knee osteoarthrosis with or without effusion. The diagnosis must be based on American College of Rheumatology (ACR) criteria. Radiological grade will be assess according to Kellgren-Lawrence scale Assessment of pain on active movement (i.e. walking) (by the patient) must be at least 40 mm on a 100 mm VAS Patient who received at least two courses of at least ten days within the last three months with non-steroidal antiinflammatory drugs (NSAID) and/or who are treated continuously for the last two month with slow-acting anti-osteoarthritis drugs Patient's informed written consent obtained in accordance with French legislation Exclusion Criteria: Patient suffering from acute congestive osteoarthritis flare of the target knee (at the time of inclusion) which means that concomitantly to knee effusion at least 2 of the following criteria are present: nocturnal disturbances due to knee pain morning stiffness over 45 minutes increase of knee pain more than 50% within the last week articular reddening articular heat Intra-articular administration of hyaluronic acid in the target knee within the previous year Intra-articular administration of hyaluronic acid in the target knee within the three previous months Any other intra-articular injection in the target knee within the last 6 months Any contraindication to intra-articular injections Present or past history of infected target knee joint Previous prosthesis knee surgery, tibial osteotomy, synovectomy or synoviorthese of the target knee Arthroscopy, articular lavage, debridement, menisectomy of the target knee within the previous year Planned knee surgery within the nine following month Any other musculoskeletal disorders that can interfere with osteoarthritis diagnosis or the evaluation of its severity Known hypersensitivity to avian products Presence of lymphatic or venous stasis Pregnancy or breastfeeding Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, haematological disease, mental disturbance Participation in another clinical trial during this study or during the previous month Previous participation in this trial Patient who requires help concerning shopping or house keeping Patient unable to comply with the protocol (e.g. patient unable to attend each trial visit or to fill the diary booklet or the quality of life questionnaire)

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com
    Description
    Related Info

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    Effectiveness and Safety of Synvisc® Versus Usual Treatments in Patients With Knee Osteoarthritis

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