A multicentre study to assess the safety and efficacy of sodium hyaluronate (Hyalgan-F) produced by fermentation in knee psteoarthritis.

Phase 1

Active, not recruiting

• Conditions: Knee oasteoarthritis

• Registration Number: EUCTR2005-002735-27-LV
• Lead Sponsor: Fidia Farmaceutici SpA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-23
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 120

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
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the potential immunogenicity of Hyalgan-F (HA-F) a sodium hyaluronate obtained by fermentation and administered by intra-articular (i.a.) route (5 i.a., once a wek for 5 weeks) in a patients with knee osteoarthritis (OA).;Secondary Objective: To evaluate the general safety (AEs. variation in haematological & biochemical parameters) and the efficacy (VAS pain relief and amelioration in the WOMAC Index, patient's and Investigator's overall judgement) of HA-F in the long term after 5 i.a. injections.;Primary end point(s): The study will start with the recruitment of the first patient and will finish with the last visit (month 6) performed on the last patient inserted.