Randomised placebo controlled trial on the safety and efficacy of Biolane in osteoarthritis

Phase 2

• Conditions: Osteoarthritis of the knees and/or hips; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12606000024549
• Lead Sponsor: Healtheries of New Zealand Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Total WOMAC score of >30 at baseline-x-ray and clinical evidence of osteoarthritis of the knees and/or hips.

Exclusion Criteria

Gout, rheumatoid arthritis or other inflammatory joint condition-Allergy to seafood or gelatine-Use of monoamine oxidase inhibitors-Use of corticosteroids within 4 weeks prior to baseline and throughout the study-Use of aspirin or anti-inflammatory agents 3 weeks prior to baseline and for the duration of the study-Use of complementary anti-arthritic medicines 6 weeks prior to baseline and for the duration of the study-Liver function tests greater then 3 times the upper limit of normal at baseline.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcomes will be assessed using the Western Ontario and McMaster Universities (WOMAC) OA index.[WOMAC is measured at baseline and weeks 6, 12 and 18.]

Secondary Outcome Measures

Name	Time	Method
Comprehensive Osteoarthritis Test (COAT) and Short Form-36.[At baseline and weeks 6, 12 and 18.];Blood safety measures[At baseline and weeks 12 and 18.];Laboratory assays to assess fibrinolysis, coagulation, inflammation, cartilage synthesis and degradation and bone formation and resorption.[At baseline and weeks 12 and 18.]