Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000024549
Ethics application status
Approved
Date submitted
16/01/2006
Date registered
19/01/2006
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised placebo controlled trial on the safety and efficacy of Biolane in osteoarthritis
Scientific title
Randomised placebo controlled trial on the safety and efficacy of Biolane in osteoarthritis of the knees and/or hips
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knees and/or hips 985 0
Condition category
Condition code
Musculoskeletal 1060 1060 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Biolane for a period of 18 weeks
Intervention code [1] 839 0
Treatment: Other
Comparator / control treatment
placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1422 0
Clinical outcomes will be assessed using the Western Ontario and McMaster Universities (WOMAC) OA index.
Timepoint [1] 1422 0
WOMAC is measured at baseline and weeks 6, 12 and 18.
Secondary outcome [1] 2505 0
Comprehensive Osteoarthritis Test (COAT) and Short Form-36.
Timepoint [1] 2505 0
At baseline and weeks 6, 12 and 18.
Secondary outcome [2] 2506 0
Blood safety measures
Timepoint [2] 2506 0
At baseline and weeks 12 and 18.
Secondary outcome [3] 2507 0
Laboratory assays to assess fibrinolysis, coagulation, inflammation, cartilage synthesis and degradation and bone formation and resorption.
Timepoint [3] 2507 0
At baseline and weeks 12 and 18.

Eligibility
Key inclusion criteria
Total WOMAC score of >30 at baseline-x-ray and clinical evidence of osteoarthritis of the knees and/or hips.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Gout, rheumatoid arthritis or other inflammatory joint condition-Allergy to seafood or gelatine-Use of monoamine oxidase inhibitors-Use of corticosteroids within 4 weeks prior to baseline and throughout the study-Use of aspirin or anti-inflammatory agents 3 weeks prior to baseline and for the duration of the study-Use of complementary anti-arthritic medicines 6 weeks prior to baseline and for the duration of the study-Liver function tests greater then 3 times the upper limit of normal at baseline.

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)
Study medications supplied in numbered containers by the sponsor
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation scheme
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1161 0
Commercial sector/Industry
Name [1] 1161 0
Healtheries of New Zealand Ltd
Country [1] 1161 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Healtheries of New Zealand Ltd
Address
Country
New Zealand
Secondary sponsor category [1] 1022 0
None
Name [1] 1022 0
N/A
Address [1] 1022 0
Country [1] 1022 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2478 0
Australian Centre for Complementary Medicine Education and Research, Mater Health Services
Ethics committee address [1] 2478 0
Ethics committee country [1] 2478 0
Australia
Date submitted for ethics approval [1] 2478 0
Approval date [1] 2478 0
Ethics approval number [1] 2478 0

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

Contacts
Principal investigator
Name 35475 0
Address 35475 0
Country 35475 0
Phone 35475 0
Fax 35475 0
Email 35475 0
Contact person for public queries
Name 10028 0
Trudi Cattley
Address 10028 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
Level 2
Community Services Building
Mater Health Services
South Brisbane QLD 4101
Country 10028 0
Australia
Phone 10028 0
+61 7 30103311
Fax 10028 0
+61 7 38406119
Email 10028 0
[email protected]
Contact person for scientific queries
Name 956 0
Dr Phillip Cheras
Address 956 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
Level 2
Community Services Building
Mater Health Services
South Brisbane QLD 4101
Country 956 0
Australia
Phone 956 0
+61 7 38406120
Fax 956 0
+61 7 38406119
Email 956 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.