A Prospective, Randomized, Parallel Group, Open Label, Multi-centric, Active Controlled Study to Evaluate the Efficacy and Safety of fixed dose combination of Etoricoxib(60mg) and Thiocolchicoside (4mg) vs Chlorzoxazone(500mg) and Diclofenac(50mg) and Paracetamol(325mg) in Low Back Pain.

MANKIND PHARMA LTD0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1. Subjects of either sex in the age range of 18-70 years (both age inclusive) with a history of LBP
•and muscle spasm of Ã¢â?°Â¤14 days, with a Wong Bakers Faces Pain scale score >4
•2. Willing to give written informed consent and comply with study procedures.

•1. Subjects with back pain due to fractures, malignancy, infection, abnormal metabolism,
•osteoarthritis of hip or any other disease,
•2. Back pain originating or referred from other organs,
•3. Subjects with a history of peptic ulceration or gastrointestinal bleeding or severe dyspepsia,
•MC/BRT/21-002
•Version: 1.0 dated 03 Feb 2022 Confidential Page 21 of 40
•4. Subjects with known allergy to NSAIDs and skeletal muscle relaxants or any component of
•the study product
•5. Subjects suffering from asthma or other allergic disorders,
•6. Subjects with severe comorbid systemic disease including bleedings diathesis, currently on
•anticoagulation therapy, hepatic or renal impairment, clinically significant cardiac disease,
•neurological disease, or psychiatric disorder
•7. Pregnant or lactating women
•8. History or evidence of spinal disease (eg, ankylosing spondylitis, rheumatoid arthritis, tumor,
•and Paget disease).

发起方

MANKIND PHARMA LTD