CTRI/2011/07/001911CompletedPhase 3
A randomized double-blind placebo-controlled study to determine whether Flexsure is safe, tolerable and effective in relieving symptoms of moderate osteoarthritis of the knee. - None
Vital gNetics0 sites60 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Diagnosed of OA of the knee according to the ACR clinical and radiographic criteria.
- •2.ARA functional class II or III.
- •3.Kellgren Lawrence radiological severity of Grade II, Grade III OA knee.
- •4.Maximal OA pain on movement, as measured on a 0-100 Visual analog scale (VAS) should be 40 80 in the previous 24 hrs at screening and baseline visits.
Exclusion Criteria
- •1.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
- •2.BMI 35 kg/m2
- •3.Indication of surgery for OA knee
- •4.Arthroscopy of either knee in the past year
- •5.Use of analgesics or any other symptom-relieving medication within 7 days of screening
- •6.Use of systemic steroids or herbal medication for OA within 4 weeks of screening
- •7.Use of Vit. D3 injections, Glucosamine sulphate, Chondroitin sulphate, Diacerin, Alendronate in the past 3 months
- •8.Administration of intra-articular steroids in the past 3 month or hyaluronic acid in the last 9 months
- •9.History of osteoporotic/ osteoarthritic fractures within the past 6 months
- •10.Pregnant or lactating women or women with inadequate contraceptive measures
- •11.Evidence or clinical suspicion of any major medical conditions (E.g. uncontrolled diabetes mellitus, uncontrolled hypertension, cardiovascular disease, thyroid, hepatic, renal dysfunction)
- •12.Presence of any clinically significant laboratory anomaly
- •13.Known cases of AIDS (HIV positive)
- •14.History of Coronary Angioplasty/CABG within the past 2 years
- •15.Moderate to severe peripheral neuropathy or other neurological disorders
- •16.Alcohol abuse, medication or drug dependence
- •17.Concurrent or previous participation in a clinical study within previous 6 weeks
Investigators
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