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Trial registered on ANZCTR


Registration number
ACTRN12613000654752
Ethics application status
Approved
Date submitted
21/11/2011
Date registered
14/06/2013
Date last updated
14/06/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of a Marinova Seaweed Extract on Osteoarthritis
Scientific title
A Randomised Controlled Trial of Adults with Osteoarthritis treated with a Marinova Seaweed Extract compared to a Placebo measured by the Comprehensive Osteoarthritis Test (COAT).
Secondary ID [1] 262835 0
Nil
Universal Trial Number (UTN)
UTN: U1111-1123-7318
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 285633 0
Condition category
Condition code
Musculoskeletal 270724 270724 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
500mg capsule taken orally twice daily containing 150mg Fucus vesiculosis (seaweed) extract and 350mg Microcrystaline Cellulose (MCC)
for 12 weeks.
Intervention code [1] 269189 0
Treatment: Other
Comparator / control treatment
500mg capsule taken twice daily containing 500mg MCC for 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 269430 0
Comprehensive Osteoarthritis Test (COAT) consisting of 4 items measured on 100mm visual analogue scale (VAS) response scales: joint pain, stiffness, difficulties with physical activities, overall symptoms.
Timepoint [1] 269430 0
Baseline, week4, week 8, week 12
Secondary outcome [1] 287623 0
high sensitivity C-reactive protein (CRP) by blood analysis.
Timepoint [1] 287623 0
Baseline and week 12
Secondary outcome [2] 287624 0
Interleukin 6 (IL-6) by blood analysis
Timepoint [2] 287624 0
Baseline and week 12
Secondary outcome [3] 287625 0
Tumour Necrosis Factor alpha (TNF-alpha) by blood analysis.
Timepoint [3] 287625 0
Baseline and week 12
Secondary outcome [4] 287626 0
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC). The Index is self-administered and assesses the three dimensions of pain, disability and joint stiffness in knee and hip osteoarthritis using a battery of 24 questions.
Timepoint [4] 287626 0
Baseline, week 4, week 8, week 12
Secondary outcome [5] 294128 0
Radial arterial pressure wave using SphygmoCor technology equiptment for assessment.
Timepoint [5] 294128 0
Baseline and week 12

Eligibility
Key inclusion criteria
Females and males, aged between 18 and 85 years.
X-ray and clinical evidence of osteoarthritis of the knees.
In good general health.
Adequate venous access.
Female participants of childbearing age who agree to continue using birth control measures for the duration of the study.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A history of trauma associated with the affected joint.
Rheumatoid or other inflammatory joint conditions.
Gout.
Individuals with thyroid disorder.
Individuals with diabetes.
Individuals taking Warfarin of other anti-coagulant medication.
Participants with a VAS score above 7 at baseline.
Participants who have just commenced on a treatment regimen for arthritis.
Use of corticosteroids (intra-articular or systematic) within 4 weeks prior to baseline and throughout the study.
Liver function tests greater than 3 times the upper limit of normal at baseline.
History of alcohol or substance abuse.
History of allergy to iodine or shell fish.
Female participants who are lactating, pregnant or planning to become pregnant.
Participants who have participated in another clinical trial in the last 30 days.
Participants unwilling to comply with the study protocol.
Participants unable to complete COAT scale appropriately.
Any 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)
Participant allocation will be according to an independently generated schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block design
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 4354 0
2480
Recruitment postcode(s) [2] 4355 0
2481
Recruitment postcode(s) [3] 4356 0
2450
Recruitment postcode(s) [4] 4357 0
2485

Funding & Sponsors
Funding source category [1] 269659 0
Commercial sector/Industry
Name [1] 269659 0
Marinova Pty Ltd
Address [1] 269659 0
249 Kennedy Drive
Cambridge
Tasmania 7170
Country [1] 269659 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Marinova Pty Ltd
Address
249 Kennedy Drive
Cambridge
Tasmania 7170
Country
Australia
Secondary sponsor category [1] 266697 0
None
Name [1] 266697 0
Address [1] 266697 0
Country [1] 266697 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269608 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 269608 0
Military Road
East Lismore NSW 2480
Ethics committee country [1] 269608 0
Australia
Date submitted for ethics approval [1] 269608 0
Approval date [1] 269608 0
23/06/2011
Ethics approval number [1] 269608 0
ECN-11-129

Summary
Brief summary
The purpose of the study is to determine the efficacy and safety of a Marinova seaweed supplement in improving symptoms in participants with diagnosed osteoarthritis of the knee. The primary hypothesis is that the oral administration of the study medication over 12 weeks will result in a statistically significant decrease in osteoarthritis symptoms in comparison with a placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33020 0
Prof Stephen Myers
Address 33020 0
NatMed Research
Rifle Range Rd
East Lismore NSW 2480
Country 33020 0
Australia
Phone 33020 0
61-2-6620 3643
Fax 33020 0
Email 33020 0
smyers@scu.edu.au
Contact person for public queries
Name 16267 0
Prof Stephen Myers
Address 16267 0
NatMed Research
Rifle Range Rd
East Lismore NSW 2480
Country 16267 0
Australia
Phone 16267 0
61-2-6620 3643
Fax 16267 0
61-2-6620 3307
Email 16267 0
smyers@scu.edu.au
Contact person for scientific queries
Name 7195 0
Prof Stephen Myers
Address 7195 0
NatMed-Research
Southern Cross Plant Science
Rifle Range Rd
East Lismore NSW 2480
Country 7195 0
Australia
Phone 7195 0
61-2-6620 3643
Fax 7195 0
61-2-6620 3307
Email 7195 0
smyers@scu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary