A Multicentric, Randomized, Comparative Clinical Trial to Evaluate the Efficacy and Safety of Dexketoprofen ER Tablet in the Treatment of Osteoarthritis

Emcure Pharmaceuticals Ltd, Pune11 个研究点分布在 1 个国家目标入组 0 人开始时间: 待定

适应症

试验速览

阶段: 3 期
发起方
试验地点: 11
主要终点: Responder rate (patients with at least 20% improvement in WOMAC total Score)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a multicentric, randomized, open lable, comparative clinical trial to compare the efficacy and safety of Dexketoprofen extended release Tablet versus Dexketoprofen immediate release tablet in the treatment of osteoarthritis. After satisfing exclusion and inclusion criteria, subjects with osteoarthritis will be randomized to two treatment groups: Dexketoprofen ER tablets and Dexketoprofen IR tablets. The efficacy and safety variables will be assessed after 14 days and 28 days of therapy. The results will be compared between two groups. Any Adverse event repored will be recorded.

研究设计

分配方式: Computer generated randomization
盲法: Open Label

入排标准

入选标准

•Male or female patients between 40-75 years of age.?
•Willing to give written informed consent and willing to comply with trial protocol.
•Clinically and/or radiologically diagnosed to have OA or are known OA patients?
•Patient and / or physician?s global assessment of arthritic condition as fair, poor or very poor.
•Patients with normal laboratory values.
•Patients not on any anti-inflammatory or other therapy known to affect the study outcome.

排除标准

•Patients with history of any drug allergy or intolerance to NSAIDs. ?
•Severe hypertension or uncontrolled hypertension?
•Patients with H/O or evidence of renal, hepatic or neurologic diseases?
•Uncontrolled diabetes?
•Women who are pregnant, lactating, of child bearing potential who are not practicing effective methods of contraception.?
•Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.

结局指标

主要结局

Responder rate (patients with at least 20% improvement in WOMAC total Score)

时间窗: Baseline, after 14 and 28 days of therapy.

次要结局

1)Improvement in average VAS score 2)Improvement in average WOMAC scores for pain, stiffness and physical function 3)Improvement in patient?s and physician?s global assessment of arthritis.(Baseline, after 14 and 28 days of therapy.)

研究者

发起方

Emcure Pharmaceuticals Ltd, Pune

研究点 (11)

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