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临床试验/NCT00921505
NCT00921505已完成4 期

The Effect of Ibuprofen, Paracetamol and Their Combination on Reactive Oxygen Species (ROS)- Production in Leukocytes and Platelet Activation

Ullevaal University Hospital1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
7
试验地点
1
主要终点
Leukocyte radical oxygen species (ROS) production

研究概览

简要总结

The purpose of this study is to determine whether paracetamol, ibuprofen or their combination can modify generation of radical oxygen species (ROS) from stimulated neutrophils.

详细描述

Non-steroidal anti-inflammatory drugs (NSAID) are used to alleviate clinical inflammatory symptoms (e.g. pain, swelling and reduced function). Leukocytes, upon activation during inflammatory states, generate radical oxygen species (ROS) which primarily are intended for host defence against invading pathogens. Certain NSAID can modify the generation of ROS from stimulated neutrophils ranging form increased production to reduced production. Preliminary experiments in our laboratory have shown that different NSAIDs have opposing effects on the ability of leukocytes (granulocytes and monocytes) to produce ROS upon a standardized stimulus, i.e. phorbol myristate acetate (PMA). Paracetamol has a marked inhibitory effect and ibuprofen has a facilitating effect on ROS production. An inhibitory effect of paracetamol was also seen when examining platelet activation markers, whereas acetylsalicylic acid showed a clear enhancing effect in this respect. We want to examine if intake of paracetamol or ibuprofen in vivo have similar effects on leukocyte ROS production and platelet activation, respectively.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteers of both sexes (ASA type I).
  • Females who are not pregnant or plan conception. (A pregnancy test will be conducted before each test day)
  • Persons who have not used analgesics for 3 days prior to the blood sampling.
  • Persons without known active peptic ulcer or gastrointestinal bleeding.
  • Persons without any known hypersensitivity for NSAIDs.
  • Persons under no other drug treatment than contraceptives.
  • Age 18 to 35 years of Caucasian origin

排除标准

  • Pregnancy during the test period.
  • Development of active peptic ulcer during the test period.
  • Change in medication status during the test period (after inclusion).

研究组 & 干预措施

Ibuprofen 400 mg

Active Comparator

Ibuprofen oral single dose

干预措施: Ibuprofen (Drug)

Ibuprofen 1200 mg

Active Comparator

Ibuprofen oral single dose

干预措施: Ibuprofen (Drug)

Paracetamol (acetaminophen) 1000 mg

Active Comparator

Paracetamol (acetaminophen) oral single dose

干预措施: Paracetamol (acetaminophen) 1000 mg (Drug)

Ibuprofen 400 mg + paracetamol 1000 mg

Active Comparator

Paracetamol (acetaminophen) + ibuprofen oral single dose

干预措施: Paracetamol + ibuprofen (Drug)

结局指标

主要结局

Leukocyte radical oxygen species (ROS) production

时间窗: 24 hours for each crossover event

次要结局

  • Platelet activation status(24 hours for each crossover event)

研究者

发起方
Ullevaal University Hospital
申办方类型
Other

研究点 (1)

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