Hymovis™ Versus Placebo in Knee Osteoarthritis

Launched by FIDIA FARMACEUTICI S.P.A. · Jun 13, 2011

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Male or female ambulant outpatients ≥ 40 years of age with an active lifestyle:
• • 2. Has a medical history of OA symptoms confirmed at least 3 months prior to the screening visit with radiographic evidence of OA, Kellgren-Lawrence grade 2-3
• • 3. Discontinuation of any analgesic/NSAID therapy prior to baseline with no intent to resume during study
• Exclusion Criteria:
• • 1. Clinically significant apparent large effusion of the target knee;
• • 2. Clinically significant valgus/varus deformities, ligamentous laxity or meniscal instability as assessed by the Investigator;
• • 3. Any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee such as Paget's disease
• • 4. Medical history of anaphylactic reactions
• • 5. History of septic arthritis in any joint
• • 6. Females who are pregnant or breast-feeding