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临床试验/NCT00917514
NCT00917514已完成不适用

An Investigational Study to Test Usability of the Electronic Dosing Equipment Medicpen During Azathioprine Treatment in Patients With Crohn's Disease or Ulcerative Colitis

Medicpen AB1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
User friendliness of Dosing Tool MedicPen

研究概览

简要总结

This is a study of the electronical dosing tool MedicPen and it's qualities with regards to user friendliness and medication compliance.

详细描述

The medical device MedicPen will be investigated for it's qualities with regards to medication compliance and user friendliness. The patient group selected here is patients with Crohn's disease that are treated with Azathioprine. The patient selection was made since the metabolite can be easily measured and the compliance can be therefore be followed. The treatment will follow the standard care given to these patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Male or female
  • 18 years or older
  • Provided written informed consent
  • Diagnosed with Chron's disease or Ulcerative Colitis
  • Treated with Azathiprine for at least 6 months prior to study start

排除标准

  • Patients who are, for some reason, judged by the responsible investigator to be unable to handle the device to be tested.

结局指标

主要结局

User friendliness of Dosing Tool MedicPen

时间窗: June 2009 to Nov 2009

次要结局

  • Measure treatment compliance(June 2009 to Nov 2009)

研究者

发起方
Medicpen AB
申办方类型
Industry

研究点 (1)

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