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Trial registered on ANZCTR


Registration number
ACTRN12616000975493
Ethics application status
Approved
Date submitted
19/07/2016
Date registered
25/07/2016
Date last updated
27/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of a marine extract for the treatment of osteoarthritis.
Scientific title
An Open Label Phase II Study on a Marine Extract on Osteoarthritis.
Secondary ID [1] 289711 0
Nil
Universal Trial Number (UTN)
U1111-1185-5009
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 299526 0
Condition category
Condition code
Alternative and Complementary Medicine 299503 299503 0 0
Other alternative and complementary medicine
Musculoskeletal 299504 299504 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Medication: Oral capsules of standardised New Zealand Green-Lipped Mussel Lipid Extract (PCSO-524)
Dosage: Participants will be randomised to receive either 200mg (given as 2x50mg morning and night); OR 400mg daily (given as 2x100mg morning and night)
Duration: 12 weeks
Intervention code [1] 295340 0
Treatment: Other
Comparator / control treatment
No control group
Open label Phase II study - randomised to two doses
Control group
Dose comparison

Outcomes
Primary outcome [1] 298988 0
Comprehensive Osteoarthritis Test (COAT)
Timepoint [1] 298988 0
Daily measurements from baseline to 12 weeks (84 in total).
Primary outcome [2] 298989 0
Physical activity (measured as steps daily using accelerometer)
Timepoint [2] 298989 0
Daily measurements from baseline to 12 weeks (84 in total).
Primary outcome [3] 298990 0
Breakthrough medication - Paracetamol usage (measured by participant report)
Timepoint [3] 298990 0
Daily measurements from baseline to 12 weeks (84 in total).
Secondary outcome [1] 325825 0
WOMAC ( Western Ontario and McMaster Universities Arthritis Index)
Timepoint [1] 325825 0
Measured (3 occasions): baseline, 6 weeks and 12 weeks
Secondary outcome [2] 325827 0
Osteoarthritis Research Society International (OARSI) Core Tests -
40m Fast Paced Walk;
30sec Chair Stand Test
Stair Climb Test
Timepoint [2] 325827 0
Measured (3 occasions): baseline, 6 weeks and 12 weeks
Secondary outcome [3] 325828 0
Grip Strength ( maximum isometric strength of the hand and forearm muscles measured by handgrip dynamometer)
Timepoint [3] 325828 0
Measured (3 occasions): baseline, 6 weeks, 12 weeks
Secondary outcome [4] 325829 0
Total Cholesterol - Plasma Sample
Timepoint [4] 325829 0
Measured (2 occasions): baseline and 12 weeks
Secondary outcome [5] 325830 0
Safety Blood Tests:
Full blood count;
Liver function test;
Urea, creatinine and electrolytes
Timepoint [5] 325830 0
Measured (2 occasions): baseline, 12 weeks
Secondary outcome [6] 325831 0
Adverse events (any untoward medical occurrence) - will be actively sought during clinical appointments and weekly phone meetings. Participants will be asked if they have experienced any new symptoms or any exacerbations of existing symptoms which will be recorded. To date adverse reactions to the treatment have been non-specific reactions and include nausea, headache and loose stools.
Timepoint [6] 325831 0
Measured (12 occasions):
Research Clinics (4 occasions): week 3, week 6, week 9 and week 12
Phone Meetings (8 occasions): week 1, week 2, week 4, week 5; week 7, week 8, week 10 and week 11.
Secondary outcome [7] 325875 0
Triglycerides - Serum Sample
Timepoint [7] 325875 0
Measured (2 occasions): baseline and 12 weeks
Secondary outcome [8] 325876 0
LDL Cholesterol - Plasma sample
Timepoint [8] 325876 0
Measured (2 occasions): baseline and 12 weeks
Secondary outcome [9] 325877 0
HDL Cholesterol - By estimation from other cholesterol fractions
Timepoint [9] 325877 0
Measured (2 occasions): baseline and 12 weeks

Eligibility
Key inclusion criteria
Women:
45-75 years of age (yoa) with a history of knee OA; onset 45 yoa or older; perceived pain between 30 and 70 on a 100mm visual analogue scale (VAS); X-ray evidence of osteoarthritis (KL score = 2 or 3); Follicle Stimulating Hormone (FSH) > 18.0 U/L; BMI < 35; otherwise healthy.
Men:
45-80 years of age (yoa) with a history of kneeOA; onset 43 yoa or older; perceived pain between 30 and 70 on a 100mm visual analogue scale (VAS); X-ray evidence of osteoarthritis (KL score = 2 or 3); BMI < 35; central obesity); otherwise healthy.
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Perceived pain <30 or >70 on a 100mm VAS; any significant active chronic disease; taking any anti-inflammatory or anti-arthritic medicines.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be randomised to receive either 200mg or 400mg dosage
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculation with alpha and beta set at 0.05 and 0.8 respectively and an effect size of 0.3 requires a minimum of 22 people per arm. We aim to enroll 60 participants (30 women and 30 men) to complete 25 participants in each arm (50 in total).
A multilevel repeated measures analysis will be undertaken over the 84 daily measurements and 2 doses using SPSS. The analysis will look at the total population and then women and men separately.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/07/2016
Actual
25/07/2016
Date of last participant enrolment
Anticipated
23/08/2016
Actual
Date of last data collection
Anticipated
15/11/2016
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 13642 0
2480 - Lismore
Recruitment postcode(s) [2] 13643 0
2485 - Tweed Heads

Funding & Sponsors
Funding source category [1] 294093 0
Commercial sector/Industry
Name [1] 294093 0
Pharmalink International Ltd
Country [1] 294093 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
NatMed Research
Address
9 Bundjalung St. Evans Head NSW 2473 AUSTRALIA
Country
Australia
Secondary sponsor category [1] 292925 0
University
Name [1] 292925 0
Southern Cross University
Address [1] 292925 0
Military Rd, Lismore NSW 2480
Country [1] 292925 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295508 0
Human Research Ethics Committee, Southern Cross University
Ethics committee address [1] 295508 0
Military Rd., Lismore NSW 2480
Ethics committee country [1] 295508 0
Australia
Date submitted for ethics approval [1] 295508 0
10/12/2015
Approval date [1] 295508 0
14/12/2015
Ethics approval number [1] 295508 0
ECN-15-328

Summary
Brief summary
The primary objective of this clinical research is to establish the effects of a standardised green-lipped mussel lipid extract (PCSO-524) in women and men with osteoarthritis (OA) of the knee. The study seeks to determine the effective dosage and will be conducted using an open-label design and is categorised as a Phase II clinical trial. Participants meeting the enrolment criteria will be randomised to either 200mg or 400mg daily for a 12 week period. The primary validated measurement will be the Comprehensive Osteoarthritis Test (COAT) which we developed in previous clinical trials on OA. The results will be used to inform a Phase III randomised controlled study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67534 0
Prof Stephen P Myers
Address 67534 0
NatMed Research
Division of Research
Southern Cross University
Military Rd.,
Lismore NSW 2480
Country 67534 0
Australia
Phone 67534 0
+61266203000
Fax 67534 0
+61266203307
Email 67534 0
[email protected]
Contact person for public queries
Name 67535 0
Shelley Robinson
Address 67535 0
NatMed Research
Division of Research
Southern Cross University
Military Rd.,
Lismore NSW 2480
Country 67535 0
Australia
Phone 67535 0
+61419098018
Fax 67535 0
+61266203307
Email 67535 0
[email protected]
Contact person for scientific queries
Name 67536 0
Myers
Address 67536 0
NatMed Research
Division of Research
Southern Cross University
Military Rd.,
Lismore NSW 2480
Country 67536 0
Australia
Phone 67536 0
+61266203000
Fax 67536 0
+61266203307
Email 67536 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
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Documents added automatically
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