RecruitingPhase 2ACTRN12616000975493

Efficacy and safety of a marine extract for the treatment of osteoarthritis.

An Open Label Phase II Study on a Marine Extract on Osteoarthritis.

Sponsor

NatMed Research

Enrollment

60 participants

Start Date

Jul 25, 2016

Study Type

Interventional

Conditions

Osteoarthritis of the knee

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.

Eligibility

Sex: Both males and femalesMin Age: 45 YearssMax Age: 80 Yearss

Inclusion Criteria4

Women:
-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:
-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.

Exclusion Criteria1

Perceived pain <30 or >70 on a 100mm VAS; any significant active chronic disease; taking any anti-inflammatory or anti-arthritic medicines.

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Interventions

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

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