Efficacy and Safety of 3 Different Dosage Regimens of Hyaluronic Acid in Patients With Knee Osteoarthritis (OA)

Meiji Seika Pharma

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis of the Knee

Treatments

Drug: Hyaluronic acid 1 x 5 ml

Drug: Hyaluronic acid 5 x 2.5 ml

Drug: Hyaluronic acid 2 x 5 ml

Study type

Interventional

Funder types

Industry

Identifiers

TM-ME3710/403

2010-021633-31 (EudraCT Number)

Details and patient eligibility

About

The main objective is the comparison of three different dosage regimens of hyaluronic acid in the treatment of osteoarthritis of the knee.

Enrollment

45 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Outpatient>45 years of age diagnosed with primary osteoarthritis according to ACR and Kellgren criteria
Knee pain ≥ 55 mm and ≤90 mm measured by Visual Analogue Scale (VAS) 100 mm
Ability to understand and follow study procedures
Written informed consent

Exclusion criteria

Patients with secondary osteoarthritis of the knee according to ACR criteria.
Severe inflammation of the knee diagnosed by physical examination or a sedimentation speed rate < 40 mm/h and serum rheumatoid factor titre < 1:40
Patients having previously received surgery, including arthroscopy
Patients with joint inflammatory disease (spondilitis, systemic rheumatoid arthritis), microcrystalline arthropathies (chondrocalcinosis, gout, fibromyalgia) and significant osteoarthritis symptoms in other joints apart from the knee, and which require pharmacological treatment
Previous administration of any of the following treatments: hyaluronic acid ia (last year); steroids i.a. or joint lavage (last 3 months), glucosamine sulfate, chondroitin sulfate or diacerein (last 3 months), NSAIDs (last 14 days), any investigational drug (last month) or its administration during this study