Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000529640
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
26/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mechanisms of Action of Glucosamine Hydrochloride / Chondroitin Sulphate (Cosamin￤) and Clinical Response in Osteoarthritis ⿿ a Pilot Study
Scientific title
Mechanisms of Action of Glucosamine Hydrochloride / Chondroitin Sulphate (Cosamin￤) and Clinical Response in Osteoarthritis ⿿ a Pilot Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 654 0
Condition category
Condition code
Musculoskeletal 727 727 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
500mg Glucosamine Hydrochloride / 400mg Chondroitin Sulphate (Cosamin DS) twice dailyover a 12 week period.
Intervention code [1] 550 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 889 0
The change in coagulation from baseline to endpoint (12 weeks)
Timepoint [1] 889 0
Primary outcome [2] 890 0
The change in fibrinolysis from baseline to endpoint (12 weeks)
Timepoint [2] 890 0
Primary outcome [3] 891 0
The change in lipids from baseline to endpoint (12 weeks)
Timepoint [3] 891 0
Primary outcome [4] 892 0
The change in inflammation from baseline to endpoint (12 weeks)
Timepoint [4] 892 0
Primary outcome [5] 893 0
The change in cartilage from baseline to endpoint (12 weeks)
Timepoint [5] 893 0
Primary outcome [6] 894 0
The change in bone degradation markers from baseline to endpoint (12 weeks)
Timepoint [6] 894 0
Secondary outcome [1] 1753 0
The change in WOMAC score
Timepoint [1] 1753 0
From baseline to endpoint (12 weeks).

Eligibility
Key inclusion criteria
Subjects with a diagnosis of OA of the hip or knee, with or without other joint involvement, as defined by:i) hip or knee pain while standing, walking and/or in motion of at least 3 months duration, andii) evidence of one or more of the following features in an X-ray picture: osteophytes, osteosclerosis, cysts or joint space narrowing, andiii) a total WOMAC score of 10 or more at study commencementSubjects who have given their informed written consent.Subjects willing to discontinue their current OA treatment for the study duration, commencing at least 4 weeks prior to study commencement. This includes treatment with intra-articular injections, corticosteroids, NSAIDs, non-prescription therapies, chondroprotective agents, occlusive dressings, physiotherapy, or orthopaedic technical measures.Subjects of childbearing age who agree to continue using contraceptive measures for the duration of the study.Subjects with good venous access.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe false alignment of the axis of the knee or hip.Surgery on the knee or hip within the past 2 months or arthroscopy within the past 2 months.Administration of intra-articular injections (e.g. corticosteroids, chondroprotective agents) or treatment with any long acting osteoarthritic therapy in the previous 2 months.Infectious or inflammatory diseases.Female subjects who are pregnant or lactating.Subjects who are unwilling to comply with the study requirements including discontinuation of current osteoarthritis treatment.Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.Subjects with contra-indications to the study medication or to paracetamol.Reliance on the use of lipolytic, fibrinolytic, anti-coagulant or anti-inflammatory agents or agents that influence platelet function (including but not restricted to - aspirin, aspirin containing compounds and other NSAIDs).A history of trauma associated with the affected joints.Subjects with significant gastrointestinal or renal disease.Subjects with any bleeding disorder.Subjects with a history of alcohol or substance abuse.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/02/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 808 0
Commercial sector/Industry
Name [1] 808 0
Nature Vet
Country [1] 808 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Nature Vet
Address
Country
Australia
Secondary sponsor category [1] 667 0
None
Name [1] 667 0
na
Address [1] 667 0
Country [1] 667 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2076 0
Greenslope Private Hospital
Ethics committee address [1] 2076 0
Ethics committee country [1] 2076 0
Australia
Date submitted for ethics approval [1] 2076 0
Approval date [1] 2076 0
Ethics approval number [1] 2076 0

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

Contacts
Principal investigator
Name 35530 0
Address 35530 0
Country 35530 0
Phone 35530 0
Fax 35530 0
Email 35530 0
Contact person for public queries
Name 9739 0
Dr Phillip Cheras
Address 9739 0
Australian Centre for Complementary Medicine Education and Research
Mater Health Services
2nd Floor
Community Services Building
39 Annerley Rd
South Brisbane QLD 4101
Country 9739 0
Australia
Phone 9739 0
+61 7 38406120
Fax 9739 0
Email 9739 0
[email protected]
Contact person for scientific queries
Name 667 0
Dr Phillip Cheras
Address 667 0
Australian Centre for Complementary Medicine Education and Research
Mater Health Services
2nd Floor
Community Services Building
39 Annerley Rd
South Brisbane QLD 4101
Country 667 0
Australia
Phone 667 0
+61 7 38406120
Fax 667 0
Email 667 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.