A double-blind cross-over placebo controlled study of Evogen® Topical gel in the treatment of mild to moderate pain associated with osteoarthritis

Phase 2

• Conditions: Mild to moderate pain in osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12607000226404
• Lead Sponsor: Blackmore's Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

X-ray and clinical evidence of osteoarthritis of the kneesIn good general healthAdequate venous accessParticipants who are medication free or stable on Glucosamine, NSAID (non steroidal anti inflammatory drugs) or Fish Oil treatment for 3 months.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 jointRheumatoid or other inflammatory joint conditionsGoutParticipants 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 studyLiver function tests greater than 3 times the upper limit of normal at baselineHistory of alcohol or substance abuseFemale participants who are lactating, pregnant or planning to become pregnantParticipants who have participated in another clinical trial in the last 30 daysParticipants unwilling to comply with the study protocolAny other condition, which in the opinion of the investigators could compromise the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified