Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid in Patients With OA of the Knee

Meiji Seika Pharma

Status

Completed

Conditions

Osteoarthritis of the Knee

Treatments

Device: Hyaluronic acid

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00669032

TM-ME3710/304

2006-001854-28 (EudraCT Number)

Details and patient eligibility

About

The main objective is the long-term comparison (3 years and 4 months) of the efficacy and safety of repeated intra-articular administration of hyaluronic acid in the treatment of osteoarthritis of the knee.

Full description

To evaluate the efficacy and safety of repeated injections of hyaluronic acid compared with placebo over a period of 40 months.

Enrollment

446 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient > 45 years of age
Out-patient diagnosed with primary osteoarthritis of the femorotibial medial joint of the knee with clinical and radiological (Kellgren grade II-III) ACR diagnosis
Joint Space Width (JSW) > 2mm
Overall pain greater or equal to 55mm (VAS - Visual Analogue Scale 100mm) recorded in the knee,by the patient at any time during the week prior to the evaluation

Exclusion criteria

Overweight patients (body mass index > 32).
Pregnant and lactating women. Women of child-bearinge age not using effective contraception
Patients who have received intra-articular hyaluronic acid within the previous year and/or intra-articular steroids or articular lavage in the chosen knee,within the previous 3 months prior to their inclusion in the study.
AINE administration within the 14 days prior to their inclusion in the study.
Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
Immunocompromised patients or patients receiving systemic immunosuppressive therapy.
Patients with known sensitivity to HA, parcetamol or AINEs permitted as rescue medication.
Patients who have received any investigational drug within 30 days prior to visit 1, or who are scheduled for the administration of an investigational drug other than the protocol product during this study.
Patients with severely impaired central nervous system.
Patients with coagulation alterations, despite receiving treatment.
Patients with secondary osteoarthritis of the knee
Patients having previously received surgery, including arthroscopy
Patients with articular inflammatory disease