A Clinical Trial to study the effect of Oxaceprol SR Tablets for the treatment of patients with Osteoarthritis
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2019/04/018689
- Lead Sponsor
- Synokem Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 219
1.Male or female subjects, aged >=30 years to <=65 years at the time of informed consent.
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in Western Ontario and McMasters (WOMAC) individual osteoarthritis (OA) indices and Composite Index (for pain, stiffness and physical function). <br/ ><br> <br/ ><br>Improvement in Visual Analog Scale (VAS). <br/ ><br>Timepoint: At visit 1, visit 2, visit 3, visit 4 and visit 5
- Secondary Outcome Measures
Name Time Method Improvement in Subjectâ??s and Physicianâ??s Global Assessment of OsteoarthritisTimepoint: At visit 1, visit 3, visit 4 and visit 5