ACTRN12613000654752
Completed
Phase 3
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).
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Marinova Pty Ltd
- Enrollment
- 130
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Exclusion Criteria
- •A history of trauma associated with the affected joint.
- •Rheumatoid or other inflammatory joint conditions.
- •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.
Outcomes
Primary Outcomes
Not specified
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