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临床试验/CTRI/2009/091/000114
CTRI/2009/091/000114已完成3 期

Clinical study to evaluate the efficacy and tolerability of FDC of Dexketoprofen and Paracetamol in acute musculoskeletal pain

Emcure Pharmaceuticals Limited Pune0 个研究点目标入组 110 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
110

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 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.
  • comply with trial protocol.

排除标准

  • 1.Patients previously sensitive to dexketoprofen, 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

研究者

发起方
Emcure Pharmaceuticals Limited Pune

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