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临床试验/EUCTR2009-015589-74-DK
EUCTR2009-015589-74-DK进行中(未招募)不适用

A controlled, randomized, double-blind, cross-over study of the onset of analgesic effect of two formulations of ibuprofen for the treatment of pain after oral surgery.

ycomed Sweden Holding 2 AB0 个研究点目标入组 140 人开始时间: 2009年9月17日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
140

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1) Indication for surgical removal of two impacted or partly impacted mandibular
  • third molars
  • 2) Written informed consent after verbal and written information.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • A.Exclusion criteria related to Ibuprofen
  • 1) An active gastric or duodenal ulcer
  • 2) Hypersensivity to NSAIDs or ASA
  • 3) Severe liver or kidney disorder
  • 4) Bleeding disorder
  • 5) Treatment with anticoagulantia
  • B. General exclusion criteria
  • 1) Pregnancy, actual or intended
  • 2) Systemic diseases which could endanger the participating patients
  • 3) Patients who were assumed not to be able to carry out the study for instance
  • patients who were not speaking or writing local language
  • 4) Patients who are regarded to have high risk for alveolitis (dry socket pain) e.g.
  • heavy smokers and diabetic patients
  • 5) Intake of analgesics including NSAIDs for 12 hours before tooth removal of surgery
  • 6) Lack of ability or willingness to comply with the protocol
  • 7) Alcohol intake on the day of surgery.
  • 8) Drug abusers
  • 9) Other circumstances observed during the surgery, at the discretion of the
  • investigator.

研究者

发起方
ycomed Sweden Holding 2 AB

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