A Study for Moderate Osteoarthritis of the Knee

Launched by VEDIC LIFESCIENCES PVT. LTD. · Nov 23, 2011

Keywords

ClinConnect Summary

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 d...

Gender

ALL

Eligibility criteria

• 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