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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- Laboratory Adverse Events
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving symptoms of Moderate Osteoarthritis of the Knee.
Detailed Description
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
Investigators
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
Outcomes
Primary Outcomes
Laboratory Adverse Events
Time Frame: 56 Days
Assessment of Tolerability by the Subject
Time Frame: 56 Days
WOMAC - pain subscale
Time Frame: 56 Days
Clinical Adverse Events
Time Frame: 56 Days
Secondary Outcomes
- Visual Analog Scale - Pain(56 Days)
- Consumption of Rescue Medication(56 Days)
- Investigator's and Subject's Global Assessment(56 Days)