A Study for Moderate Osteoarthritis of the Knee

A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Centric Study to Determine Whether Flexsure is Safe, Tolerable and Effective in Relieving Symptoms of Moderate Osteoarthritis of the Knee

This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving symptoms of Moderate Osteoarthritis of the Knee.

Primary efficacy variable:

Number of patients showing 20% reduction from baseline in the WOMAC - pain subscale

Secondary efficacy variables:

• Number of patients showing a 50% reduction from baseline in the WOMAC - pain subscale
• Number of patients showing a 20% reduction from baseline in VAS-pain
• Number of patients showing a 50% reduction from baseline in VAS- pain
• Mean change (percentage reduction) in WOMAC scores for pain, stiffness and physical function from baseline, as compared to placebo
• Mean change (percentage reduction) in VAS - pain, as assessed at clinic visits and by daily records in patient diary (First two weeks only)
• Consumption of rescue medication
• Investigator's Global assessment of efficacy
• Subject's global assessment of efficacy

Inclusion Criteria:

• Ambulatory male or female patients aged 30-65 years, and diagnosed of OA of the knee according to the ACR clinical and radiographic criteria
• ARA functional class II or III
• Kellgren Lawrence radiological severity of Grade II, Grade III OA knee
• Maximal OA pain on movement, as measured on a 0-100 Visual analog scale (VAS) should be more than 40 and less than 80 in the previous 24 hrs at screening and baseline visits

Exclusion Criteria:

• Conditions that can mimic OA knee pain, E.g. rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, pseudo gout or pain due to malignant disease
• BMI >35 kg/m2
• Indication of surgery for OA knee
• Arthroscopy of either knee in the past year
• Use of analgesics or any other symptom-relieving medication within 7 days of screening
• Use of systemic steroids or herbal medication for OA within 4 weeks of screening
• Use of Vit. D3 injections, Glucosamine sulphate, Chondroitin sulphate, Diacerin, Alendronate in the past 3 months
• Administration of intra-articular steroids in the past 3 month or hyaluronic acid in the last 9 months
• History of osteoporotic/ osteoarthritic fractures within the past 6 months
• Pregnant or lactating women or women with inadequate contraceptive measures
• Evidence or clinical suspicion of any major medical conditions (E.g. uncontrolled diabetes mellitus, uncontrolled hypertension, cardiovascular disease, thyroid, hepatic, renal dysfunction)
• Presence of any clinically significant laboratory anomaly
• Known cases of AIDS (HIV positive)
• History of Coronary Angioplasty/CABG within the past 2 years
• Moderate to severe peripheral neuropathy or other neurological disorders
• Alcohol abuse, medication or drug dependence
• Concurrent or previous participation in a clinical study within previous 6 weeks