Health Condition 1: M199- Osteoarthritis, unspecified site Health Condition 2: null- Patients of Osteoarthritis and Post Operative Pain after Orthopaedic Surgery
Conditions
Interventions
Intervention1: Tapentadol Tablets: Four Tablets/day every 6 hours for 10 days Osteoarthritis patients) and
Four Tablets/day every 6 hours for 03 days (Post operative pain)
Control Intervention1: Tra
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subject voluntarily agrees to participate in this study and willing to sign an informed consent form prior to entry into the Screening Period. Diagnosis of OA is present for at least 6 months or post operative pain after the orthopaedic surgery. Subject is generally in good health. Subject is expected to be compliant with study procedures.
Exclusion criteria
Exclusion criteria: History of prior hypersensitivity to the study medication and/or reference drug or any similar class of drugs. Pre-existing asthma. 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. Immunocompromised states and patients with systemic infections. 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. Patients who have participated in a new drug study in the past 3 months. Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study. Conditions predisposing to gastrointestinal dysfunction (eg, history of peptic ulcer, upper gastrointestinal disease, ulcerative colitis; smoking; advancing age; concurrent corticosteroids; alcohol abuse; etc.) History of bleeding tendencies, cirrhosis and esophageal varices. Gout, pseudo-gout, Paget?s disease or any chronic pain syndrome that may interfere with assessment of the Index hip and/or knee.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of pain will measure by Visual Analog ScaleTimepoint: For Osteoarthritis : Day 0,4th ,6th & 10th day For Post operative pain:Day 0, 2nd & 3rd Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Global Assessment of efficacy and tolerabilityTimepoint: For Osteoarthritis : 10th Day For Post operative pain:3rd Day;Reduction in Tenderness, Swelling,Stiffness and improvement in MobilityTimepoint: (For Osteoarthritis)Day 0,4th ,6th & 10th day. | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd, Advent
Outcome results
None listed