NCT04358120

A Multicentre Clinical Investigation to Assess Efficacy and Safety of Intra-articular Injections of Hyaluronic Acid Combined With Chondroitin Sulfate in Knee Osteoarthritis

A Multicentre Clinical Investigation to Assess Efficacy and Safety of Intra-articular Injections of a New Viscosupplement Based on Hyaluronic Acid Combined With Chondroitin Sulfate in Patients With Knee Osteoarthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, prospective, sponsor initiated clinical investigation that aims to evaluate safety and efficacy of Hyaluronic Acid Combined With Chondroitin Sulfate in symptomatic patients with OA of the knee.

Conditions

• Osteo Arthritis Knee

Interventions

Type	Name	Description
DEVICE	Hyaluronic Acid Combined With Chondroitin Sulfate	Subjects' participation in the study will last 26 weeks. The study includes 7 visits that consist of a Screening visit, three treatment visits and three follow-up visits. Eligible subjects will undergo a Baseline visit (V1 at week 0) during which, after the confirmation of eligibility, assessments and ultrasound evaluation, the study subjects will be treated with the 1st injection of 2%Hyaluronic Acid and 2% chondroitin sulfate Subsequent treatments will be administered at weekly intervals during Visit 2 (V2 at week 1) and Visit 3 (Visit 3 at week 2) after the effectiveness assessments. Study subjects will return for Follow-up visits 1 month (Visit 4 at week 6), 3 months (Visit 5 at week 14) and 6 months (Visit 6 at week 26) after the last injection

Timeline

• Start date: 2017-11-28
• Primary completion: 2018-09-18
• Completion: 2018-09-18
• First posted: 2020-04-24
• Last updated: 2020-04-24

Locations

5 sites across 1 country: Czechia