Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00513422 |
Date of registration:
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07/08/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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The Long-term Evaluation of Glucosamine Sulphate Study
LEGS |
Scientific title:
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The Effect of Glucosamine Sulphate on Structural Disease Progression in Knee Osteoarthritis and the Cost-effectiveness of Glucosamine Sulphate for Knee Arthritis. |
Date of first enrolment:
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October 2007 |
Target sample size:
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600 |
Recruitment status: |
Active, not recruiting |
URL:
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http://clinicaltrials.gov/show/NCT00513422 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Australia
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Contacts
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Name:
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Charles Bridges-Webb, MB, BS |
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Telephone:
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Email:
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Affiliation:
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Royal College of General Practitioners |
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Name:
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Marlene Fransen, PhD, MPH |
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Email:
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Affiliation:
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University of Sydney, Faculty of Health Sciences |
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Name:
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Mark Woodward, PhD, MSc |
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Email:
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Affiliation:
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The George Institute, University of Sydney |
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Name:
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Philip Sambrook, MB, BS |
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Email:
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Affiliation:
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Institute of Bone and Joint Research, University of Sydney |
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Name:
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Richard Day, MB, BS, MD |
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Telephone:
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Email:
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Affiliation:
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University of New South Wales |
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Name:
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Lynette March, PhD, MB, BS |
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Email:
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Affiliation:
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University of Sydney |
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Name:
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Robyn Norton, PhD, MPH |
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Telephone:
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Email:
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Affiliation:
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The George Institute, University of Sydney |
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Name:
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John Edmonds, MB,BS |
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Email:
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Affiliation:
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University of New South Wales |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Knee pain, or taking NSAIDs/ analgesia for knee pain on most days past month
- Knee pain 4-10 on 10cm VAS
- Medial tibio-femoral compartment joint space narrowing in symptomatic knee
Exclusion Criteria:
- Unstable diabetes
- <2mm medial tibio-femoral compartment joint space width
Age minimum:
45 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoarthritis, Knee
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Intervention(s)
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Dietary Supplement: Chondroitin sulphate
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Dietary Supplement: Glucosamine sulphate and chondroitin
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Dietary Supplement: Glucosamine sulphate
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Dietary Supplement: Placebo capsules for glucosamine and chondroitin
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Primary Outcome(s)
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Knee pain (11 point Likert scale)
[Time Frame: Bimonthly for 1 year]
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Medial tibio-femoral joint space narrowing (mm)
[Time Frame: MRI (1 year) Radiographs (2 years)]
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Secondary Outcome(s)
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General health status (SF-12v2)
[Time Frame: 1 year, 2 years]
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Patients global assessment
[Time Frame: Bimonthly for 1 year]
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Cost-effectiveness (cost per OMERACT-OARSI responder)
[Time Frame: 2 years]
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Leisure time physical activity
[Time Frame: 1 year, 2 years]
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WOMAC
[Time Frame: 1 year, 2 years]
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Total NSAIDs use
[Time Frame: Bimonthly for 1 year]
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Secondary ID(s)
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GI-IM-LEGS-L
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NHMRC 402511
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NHMRC 402781
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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