Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000229471
Ethics application status
Approved
Date submitted
24/04/2007
Date registered
1/05/2007
Date last updated
21/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a Marinova seaweed extract on osteoarthritis
Scientific title
Participant: Individuals with osteoarthritis
Intervention: Seaweed extract
Outcome: Comprehensive Osteoarthritis test
Comparator:Dose comparison
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 1760 0
Condition category
Condition code
Musculoskeletal 1852 1852 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Seaweed extract derived from Marine macroalgae, dose complarison study. Five participants will take 100grams twice a day and five will take 1gram twice a day. The tablets will be self-administered by the participants each morning before breakfast and each evening. The study will continue for 12 weeks after the initial baseline visit, measurement points are at baseline, week 1, week 6 and week 12.
Intervention code [1] 1721 0
Treatment: Other
Comparator / control treatment
No comparator.
Control group
Dose comparison

Outcomes
Primary outcome [1] 2595 0
COAT (Comprehensive Osteoarthritis Test) - This instrument consists of four items measured on 100mm visual analogue scale (VAS) response scales:
- joint pain
- stiffness
- difficulties with physical activities
- overall symptoms
Timepoint [1] 2595 0
Measured daily for 12 weeks.
Secondary outcome [1] 4455 0
Paracetamol usage
Timepoint [1] 4455 0
Participants will record paracetamol usage on a daily basis in a study diary, logged daily for 12 weeks

Eligibility
Key inclusion criteria
X-ray and clinical evidence of osteoarthritis of the kneesIn good general healthAdequate venous accessParticipants willing to discontinue their current OA (osteoarthritis) treatment for the duration of the study. This includes treatment with intra-articular injections, corticosteroids, NSAIDs (non steroidal anti inflammatory drug), non-prescription therapies, chondroprotective agents, occlusive dressings, physiotherapy, or orthopaedic technical measuresParticipants of childbearing age who agree to continue using birth control measures for the duration of the study.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A history of trauma associated with the affected jointRheumatoid or other inflammatory joint conditionsGoutUse of corticosteroids (intra-articular or systematic) within 4 weeks prior to baseline and throughout the studyUse of anti-inflammatory agents or anti-arthritic complementary medicines 3 weeks prior to baseline and for the duration of the studyLiver function tests greater than 3 times the upper limit of normal at baselineHistory of alcohol or substance abuseFemale participants who are lactating, pregnant or planning to become pregnantParticipants who have participated in another clinical trial in the last 30 daysParticipants unwilling to comply with the study protocolAny other condition, which in the opinion of the investigators could compromise the study.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1999 0
Commercial sector/Industry
Name [1] 1999 0
Marinova Pty Ltd
Country [1] 1999 0
Primary sponsor type
Commercial sector/Industry
Name
Marinova Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 1810 0
None
Name [1] 1810 0
N/A
Address [1] 1810 0
Country [1] 1810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3706 0
NatMed-Research Department fo Natural and Complementary Medicine Southern Cross University
Ethics committee address [1] 3706 0
Lismore NSW
Ethics committee country [1] 3706 0
Australia
Date submitted for ethics approval [1] 3706 0
Approval date [1] 3706 0
16/04/2007
Ethics approval number [1] 3706 0
ECN-07-37

Summary
Brief summary
This is a pilot study designed to gather data pertinent to the development of a large scale clinical trial, The study is an open label trial to be conducted over 12 weeks in otherwise healthy individuals. The study will compare baseline Comprehensive Osteoarthritis Test (COAT) measurements with end of study outcomes
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27824 0
Address 27824 0
Country 27824 0
Phone 27824 0
Fax 27824 0
Email 27824 0
Contact person for public queries
Name 10910 0
Dr Joan O'Connor
Address 10910 0
NatMed-Research
Department of Natural and Complementary Medicine
Southern Cross University
Military Road
Lismore NSW
Country 10910 0
Australia
Phone 10910 0
02 66 20 3649
Fax 10910 0
02 66 20 3307
Email 10910 0
joconnor@scu.edu.au
Contact person for scientific queries
Name 1838 0
Dr Joan O'Connor
Address 1838 0
NatMed-Research
Department of Natural and Complementary Medicine
Southern Cross University
Military Road
Lismore NSW
Country 1838 0
Australia
Phone 1838 0
02 66 20 3649
Fax 1838 0
02 66 20 3307
Email 1838 0
joconnor@scu.edu.au

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.