Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00513422




Registration number
NCT00513422
Ethics application status
Date submitted
7/08/2007
Date registered
8/08/2007
Date last updated
30/06/2010

Titles & IDs
Public title
The Long-term Evaluation of Glucosamine Sulphate Study
Scientific title
The Effect of Glucosamine Sulphate on Structural Disease Progression in Knee Osteoarthritis and the Cost-effectiveness of Glucosamine Sulphate for Knee Arthritis.
Secondary ID [1] 0 0
NHMRC 402511
Secondary ID [2] 0 0
GI-IM-LEGS-L
Universal Trial Number (UTN)
Trial acronym
LEGS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Glucosamine sulphate and chondroitin
Treatment: Other - Glucosamine sulphate
Treatment: Other - Chondroitin sulphate
Treatment: Other - Placebo capsules for glucosamine and chondroitin

Experimental: 1 - Glucosamine sulfate 1500mg and chondroitin sulfate 800mg (low molecular weight, bovine)

Experimental: 2 - Glucosamine sulfate 1500mg

Experimental: 3 - Chondroitin sulfate 800mg

Placebo comparator: 4 - Matching glucosamine/chondroitin placebo capsules


Treatment: Other: Glucosamine sulphate and chondroitin
Glucosamine: Two 750mg capsules once daily for two years;

Chondroitin: Two 400mg capsules once daily for two years.

Treatment: Other: Glucosamine sulphate
Glucosamine: Two 750mg capsules once daily for two years;

Placebo Chondroitin: Two capsules once daily for two years.

Treatment: Other: Chondroitin sulphate
Chondroitin sulphate: Two 400mg capsules once daily for two years;

Placebo glucosamine: Two capsules once daily for two years.

Treatment: Other: Placebo capsules for glucosamine and chondroitin
Two placebo glucosamine capsules once daily for two years;

Two placebo chondroitin capsules once daily for two years.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Medial tibio-femoral joint space narrowing (mm)
Timepoint [1] 0 0
MRI (1 year) Radiographs (2 years)
Primary outcome [2] 0 0
Knee pain (11 point Likert scale)
Timepoint [2] 0 0
Bimonthly for 1 year
Secondary outcome [1] 0 0
WOMAC
Timepoint [1] 0 0
1 year, 2 years
Secondary outcome [2] 0 0
Patients global assessment
Timepoint [2] 0 0
Bimonthly for 1 year
Secondary outcome [3] 0 0
Total NSAIDs use
Timepoint [3] 0 0
Bimonthly for 1 year
Secondary outcome [4] 0 0
General health status (SF-12v2)
Timepoint [4] 0 0
1 year, 2 years
Secondary outcome [5] 0 0
Cost-effectiveness (cost per OMERACT-OARSI responder)
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Leisure time physical activity
Timepoint [6] 0 0
1 year, 2 years

Eligibility
Key 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
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Unstable diabetes
* <2mm medial tibio-femoral compartment joint space width

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2011
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Marlene Fransen - Sydney
Recruitment postcode(s) [1] 0 0
1825 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marlene Fransen, PhD, MPH
Address 0 0
University of Sydney, Faculty of Health Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00513422