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Clinical Trials/ACTRN12607000226404
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.

Registry
who.int
Start Date
April 30, 2007
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Blackmore's Pty Ltd

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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