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| Criteria | Details |
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| Inclusion | (i) Male and female subjects 40 – 75 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2. |
| (ii) Unilateral or bilateral OA of the knee for greater than 3 months (ACR criteria) |
| (iii) Subjects with radio graphic evidence by Kellgren - Lawrence grade 2 or 3 |
| (iv) Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy |
| (v) VAS score during the most painful knee movement between 40-70 mm |
| (vi) Subjects having mild-to-moderate pain not adequately or completely controlled with anti-inflammatory drugs |
| (vii) Results of screening are within normal range or considered not clinically significant by the Principal Investigator |
| (viii) Drug naive subjects or subjects willing to refrain from using ibuprofen, aspirin or other NSAIDS (other than acetaminophen/paracetamol as rescue) or any other pain reliever including topical application (OTC or prescription) and Omega 3 fatty acids during the entire trial. |
| (ix) Willing to sign the informed consent and comply with study procedure |
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| Exclusion | (i) Female subjects, who are pregnant, breast feeding or planning to become pregnant. |
| (ii) Subject has known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication |
| (iii) History of underlying inflammatory arthropathy or severe RA or OA |
| (iv) Subjects scheduled for any surgery within 3 months of completing the study |
| (v) Recent injury in the area affected by OA of the knee (past 4 months) |
| (vi) History of Gout |
| (vii) History of congestive heart failure |
| (viii) Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies |
| (ix) History of Systemic Lupus Erythematosus (SLE) |
| (x) High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) |
| (xi) History of psychiatric disorder that may impair the ability of subjects to provide written informed consent |
| (xii) Participation in any other trials involving investigational or marketed products within 30days prior to the Screening Visit |
| (xiii) Have taken any corticosteroid, indomethacin, Glucosamine + chondroitin, within 3 months prior to the Treatment Period, Day 0 (Visit 1) or intra-articular treatment / injections with corticosteroid or hyaluronic acid or Omega-3 Fatty acids dietary supplements within 6 months preceding the treatment period. |
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