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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00513422
Date of registration: 07/08/2007
Prospective Registration: Yes
Primary sponsor: University of Sydney
Public title: The Long-term Evaluation of Glucosamine Sulphate Study LEGS
Scientific title: 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: October 2007
Target sample size: 600
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT00513422
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Australia
Contacts
Name:     Charles Bridges-Webb, MB, BS
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Affiliation:  Royal College of General Practitioners
Name:     Marlene Fransen, PhD, MPH
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Affiliation:  University of Sydney, Faculty of Health Sciences
Name:     Mark Woodward, PhD, MSc
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Affiliation:  The George Institute, University of Sydney
Name:     Philip Sambrook, MB, BS
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Affiliation:  Institute of Bone and Joint Research, University of Sydney
Name:     Richard Day, MB, BS, MD
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Affiliation:  University of New South Wales
Name:     Lynette March, PhD, MB, BS
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Affiliation:  University of Sydney
Name:     Robyn Norton, PhD, MPH
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Affiliation:  The George Institute, University of Sydney
Name:     John Edmonds, MB,BS
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Affiliation:  University of New South Wales
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Osteoarthritis, Knee
Intervention(s)
Dietary Supplement: Chondroitin sulphate
Dietary Supplement: Glucosamine sulphate and chondroitin
Dietary Supplement: Glucosamine sulphate
Dietary Supplement: Placebo capsules for glucosamine and chondroitin
Primary Outcome(s)
Knee pain (11 point Likert scale) [Time Frame: Bimonthly for 1 year]
Medial tibio-femoral joint space narrowing (mm) [Time Frame: MRI (1 year) Radiographs (2 years)]
Secondary Outcome(s)
General health status (SF-12v2) [Time Frame: 1 year, 2 years]
Patients global assessment [Time Frame: Bimonthly for 1 year]
Cost-effectiveness (cost per OMERACT-OARSI responder) [Time Frame: 2 years]
Leisure time physical activity [Time Frame: 1 year, 2 years]
WOMAC [Time Frame: 1 year, 2 years]
Total NSAIDs use [Time Frame: Bimonthly for 1 year]
Secondary ID(s)
GI-IM-LEGS-L
NHMRC 402511
NHMRC 402781
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Health and Medical Research Council, Australia
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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