Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Oxaceprol SR Tablets 600 mg: One Tablet orally once daily for 6 weeks
Control Intervention1: Oxaceprol Capsules 200 mg: One Capsule orally three times daily for 6 weeks
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, aged >=30 years to 2. Clinically diagnosed with sign and symptoms of Osteoarthritis of Knee. 3. Patient having grade 1-3 in Osteoarthritis condition according to Kellgren and Lawrence grading scale. 4. Knee pain present for at least one month in the preceding three months with at least one of the following: morning stiffness less than 30 min or knee crepitus. 5. Knee pain on movement of intensity at least 40 mm or above on a 100 mm VAS (Visual Analogue Score) scale.
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing women. 2. Patients having inflammatory arthritis, gout, pseudogout, Pagetâ??s disease or any chronic pain syndrome that may interfere with assessment of the knee. 3. Prior intra-articular injection of hyaluronic acid / steroid / joint lavage in the study knee any time in the past three months. 4. Knee injury or diagnostic arthroscopy of signal knee within 6 months preceding enrolment or knee surgery (including arthroscopic surgery requiring an incision of the internal joint components) in the study knee, at any time. 5. Severe and advanced OA disease, defined as joint space width 2 mm or deformed joint, or disease necessitating knee surgery in the current year. 6. Subject unlikely to provide informed consent, follow the study protocol or any other criteria, which in the opinion of the investigator, is not conducive to enrolment of a particular subject into the trial. 7. History of bleeding tendencies, cirrhosis and oesophageal varices. 8. Hypersensitive to Oxaceprol. 9. History of hypersensitivity or allergy to NSAIDs, other COX-2 inhibitors and/or sulphonamides. 10. Pre-existing asthma. 11. Patients who would require concomitant therapy with drugs e.g. low dose aspirin, warfarin, anti-epileptics, fluconazole (inhibitor of CYP 2C9/3A4), ketoconazole (a known inhibitor of CYP 3A4) etc. 12. Immuno compromised states and patients with systemic infections. 13. Conditions predisposing to gastrointestinal dysfunction (e.g., history of peptic ulcer, upper gastrointestinal disease, ulcerative colitis; smoking; advancing age; concurrent corticosteroids; alcohol abuse; etc.). 14. Patients with severe cardiac, hepatic, renal, or cerebrovascular disease, malignancy, chronic uncontrolled systemic diseases e.g., diabetes, hypertension, collagen disorders, etc. or any other serious medical illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Western Ontario and McMasters (WOMAC) individual osteoarthritis (OA) indices and Composite Index (for pain, stiffness and physical function). Improvement in Visual Analog Scale (VAS). Timepoint: At visit 1, visit 2, visit 3, visit 4 and visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Subjectâ??s and Physicianâ??s Global Assessment of OsteoarthritisTimepoint: At visit 1, visit 3, visit 4 and visit 5 | — |
Countries
India
Contacts
Public ContactAbhinav Arora
Synokem Pharmaceuticals Ltd.
Outcome results
None listed