An open label, comparative, multicentric study to assess the efficacy and safety of fixed dose combination tablets containing Etodolac & Tolperisone hydrochloride in comparison with Tolperisone hydrochloride tablets in patients suffering from musculoskeletal disorders associated with painful muscle spasm.

Cadila Healthcare 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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•1.Patients of either sex between the age of 18-60 years.
•2.Patients with an established diagnosis of musculoskeletal disorders associated with painful muscle spasm of at least moderate severity at the time of enrolment into the study.
•3.Informed consent of the patient/relative/legal representative.

•1.Pregnancy & Lactation.
•2.Patients with hepatic and / or renal insufficiency.
•3.Patients with myasthenia gravis.
•4.Patients with active peptic ulceration within the last 6 months.
•5.Patients suffering from coronary heart disease, uncontrolled hypertension, congestive heart failure or any other significant cardiovascular disorder.
•6.Patients suffering from any hemorrhagic diasthesis.
•7.Patients with bronchial asthma, rhinitis, urticaria, or other allergic reactions induced by aspirin or other NSAIDs.
•8.Patients with hypersensitivity to Etodolac, Tolperisone hydrochloride or any other components of the formulations.
•9.Patients with any other serious concurrent illness or malignancy.
•10.Patients with continuing history of alcohol and / or drug abuse.
•11.Participation in another clinical trial in the past 3 months.

发起方