A Comparative, Randomized, double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Tapentadol Tablets 100 mg Vs Tramadol Hydrochloride Tablets 50 mg in patients of Osteoarthritis and Post Operative Pain after Orthopaedic Surgery

Ajanta Pharma Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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.

发起方