Status:
COMPLETED
A Study for Moderate Osteoarthritis of the Knee
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Collaborating Sponsors:
VitalgNetics
Conditions:
Osteoarthritis
Eligibility:
All Genders
30-65 years
Phase:
PHASE1
PHASE2
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 baseli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01478997
Start Date
August 1 2011
End Date
March 1 2012
Last Update
May 16 2012
Active Locations (2)
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1
Nasik
Nashik, Maharashtra, India, 422002
2
Pune
Pune, Maharashtra, India, 411004