EUCTR2005-002735-27-LV
Active, not recruiting
Phase 1
A multicentre study to assess the safety and efficacy of sodium hyaluronate (Hyalgan-F) produced by fermentation in knee psteoarthritis.
ConditionsKnee oasteoarthritis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Knee oasteoarthritis
- Sponsor
- Fidia Farmaceutici SpA
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Male or female outpatients above 40 years of age, ambulant (only canes are allowed as assistive device),
- •\-Suffering from primary knee osteoarthritis (OA) according to ACR diagnostic criteria (i.e., knee pain plus osteophytes \+ at least one of the following: age above 50 years, crepitus, morning stiffness above 30 minutes in duration) confirmed radiologically,
- •\-OA of II\-III degree according to Kellgren\-Lawrence,
- •\-Moderate\-severe pain after the 50ft walk on a flat surface (above 40 mm VAS) at baseline,
- •\-Discontinuation of analgesic/ NSAID therapy if previously taken prior to baseline,
- •\-Willing and able to understand and sign an approved Infromed Consent Form,
- •\-No pregnancy, not breast feeding. Females of childbearing potential (including those less than 1 year post\-menopausal) must agree to maintain reliable birth control throughout the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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