Clinical study to evaluate the efficacy and tolerability of FDC of S(+)-Etodolac and Paracetamol Tablet in acute musculoskeletal pain

Emcure Pharmaceuticals Ltd, Pune0 个研究点目标入组 100 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) Male or female patients between 18-65 years of age.
•2) Patients having acute musculoskeletal pain e.g. musculoskeletal injuries, myalgia, neck pain, limb pain, low back pain, joint pain, widespread musculoskeletal pain
•3) Patients willing to give written informed consent and willing to comply with trial protocol.

•1) Patients previously sensitive to S-Etodolac, to diclofenac, to paracetamol, to any other NSAID, or to any of the ingredients of the product
•2) Patients in whom substances with a similar action (e.g. Aspirin, or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema.
•3) Patients with active or suspected gastrointestinal ulcer or history of gastrointestinal ulcer or chronic dyspepsia.
•4) Patients who have gastrointestinal bleeding or other active bleedings or bleeding disorders.
•5) Patients with Crohn?s disease or ulcerative colitis.
•6) Patients with a history/ presence of bronchial asthma.
•7) Patients with severe heart failure
•8) Patients with moderate to severe renal dysfunction
•9) Patients with severely impaired hepatic function
•10) Patients with hemorrhagic diathesis and other coagulation disorders
•11) Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception
•12) Treatment with other analgesic and/or anti-inflammatory agent
•13) Patients who will receive some other drug during the study besides that in the protocol that could alter the bioavailability of the study drug
•14) Any condition that, in the opinion of the investigator, does not justify the patient's inclusion in the study

发起方

Emcure Pharmaceuticals Ltd, Pune