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

Fidia Farmaceutici s.p.a.5 sites in 1 country74 target enrollmentNovember 28, 2017

ConditionsOsteo Arthritis Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteo Arthritis Knee
Sponsor: Fidia Farmaceutici s.p.a.
Enrollment: 74
Locations: 5
Primary Endpoint: Change in pain score measured by Visual Analogue Scale (VAS)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 28, 2017

End Date

September 18, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fidia Farmaceutici s.p.a.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At Screening
•Male or female between the ages of 40 and 80
•Body Mass Index (BMI) ≤ 30;
•Mean knee pain score at rest over the last 24 hours evaluated on VAS (0-100) ≥
•The most painful knee is considered the target knee;
•OA of the Knee radiologically and clinically confirmed responding to criteria of American College of Rheumatology (ACR): pain of the knee and crepitus on active motion or morning stiffness less than 30 minutes or age \>50 years
•Symptomatic knee pain for more than 6 months;
•Radiological Kellgren and Lawrence grade II or III confirmed by an X-ray not older than 12 months;
•Willing to discontinue any systemic analgesic/NSAID therapy, opioids, systemic corticosteroids, skeletal muscle relaxants, and any other medication that would interfere with the study assessments, except for the rescue medication, with no intention to resume them during the clinical investigation (see Appendix 5 for wash out period);
•Patient able to comply with the instructions of the clinical investigation and to maintain a Rescue Medication Diary during the study;

Exclusion Criteria

•Related to the OA pathology
•Recent trauma (\< 1 month) of the target knee responsible for the symptomatic knee pain;
•Articular disease resulting from articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, haemophilia, hemochromatosis;
•Inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, gout and infectious arthritis, acute calcium pyrophosphate arthritis);
•Pathologies interfering with the evaluation of OA. Related to treatments
•Corticosteroids injection in the target knee in the last 3 months before first intra-articular (IA) injection;
•Hyaluronan injection in the target knee in the last 6 months before first IA injection;
•Arthroscopy and surgery in the target knee in the last 3 months before first IA injection;
•Oral corticosteroid therapy ≥ 5mg/day (in Prednisone equivalent) in the last 3 months before first IA injection;
•OA treatments based on curcuma extract in the last 3 months before first IA injection;

Outcomes

Primary Outcomes

Change in pain score measured by Visual Analogue Scale (VAS)

Time Frame: at week 6, 14 and 26

Change in pain perception from baseline in patient with knee osteoarthritis after three intra-articular 2% Chondroitin Sulfate + 2% hyaluronic Acid injections assessed by Visual Analogue Scale (VAS) (From 0 to 100) at weeks 6, 14 and 26

Secondary Outcomes

Change from baseline up to 26 weeks after first treatment on knee functional disability on Clinical Observer Global Assessment (COGA)(at weeks 6, 14 and 26)
Number of patients Responder to treatment(Weeks 6, 14 and 26)
Change from baseline in popliteal cyst at 6 weeks(at week 6)
Change from baseline in knee pain and function up to 26 weeks(at weeks 6, 14 and 26)
Change in Patient's Global Assessment(at weeks 6, 14 and 26)
Change from baseline in Synovitis at 6 weeks(at week 6)
Change from baseline in Synovial hypertrophy at 6 weeks(at week 6)
Change in Synovial Power Doppler signal at week 6(at week 6)
Change from baseline in knee Effusion at 6 weeks(at week 6)
Safety of the treatment. Number of patient with treatment related adverse events(through study completion)