ACTRN12607000226404
Not yet recruiting
Phase 2
Participants: Osteoarthritis of the kneesIntervention: Evogen® Topical gelComparator: Placebo Outcome: Reduction in VAS pain scale scores
Blackmore's Pty Ltd0 sites20 target enrollmentApril 30, 2007
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Blackmore's Pty Ltd
- Enrollment
- 20
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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