CTRI/2014/02/004373
Completed
Phase 2
A Clinical study to evaluate efficacy and safety of Ostofix Tablet in subjects suffering from Osteoarthritis of Knee(s) - NI
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ARJUN HEALTHCARE
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Symptoms of osteoarthritis in one or both knee joints for a minimum of six months and maximum for five years
- •History of knee pain due to osteoarthritis requiring the use of NSAIDs
- •Acetaminophen or another analgesic agent on a regular basis greater than or equal to three days per week for at least six months before the screening visit
- •OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria clinical and radiological
- •Subjects may take tab paracetamol greater than or equal to 2g per day or any standard analgesic drug for breakthrough pain
- •Subjects not having knee joint deformity
- •Subjects signing written informed consent and ready to comply with the protocol requirements
- •Subjects with pain VAS greater than 40 mm on weight bearing activities
Exclusion Criteria
- •Rheumatoid arthritis, gout pseudo gout inflammatory arthritis Pagets disease of bone chronic pain syndrome fibromyalgia or another major joint disease
- •History of surgery including arthroscopy or major trauma to the study joint in the previous six months before the screening visit
- •Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study
- •Signs of clinically important active inflammation of the study knee joint including redness warmth and or a large bulging effusion with the loss of normal contour at the screening and or baseline visits
- •Use of systemic corticosteroids within 2 months of screening or intra\-articular viscosupplementation within the past 3 months
- •Use of any other investigational drug within 1 month prior to randomization
- •Subjects having diabetes mellitus tuberculosis HIV Ischemic Heart Disease
- •Known other major medical or surgical disease
- •Pregnancy and Lactation.
- •Known hypersensitivity to ingredients used in study drug
Outcomes
Primary Outcomes
Not specified
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