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临床试验/EUCTR2007-005631-29-DK
EUCTR2007-005631-29-DK进行中(未招募)1 期

Cannabinoid CB1 receptor agonist treatmentin severe chronic anorexia nervosa

Center for Spiseforstyrrelse, Endokrinologisk Afdeling M, Odense Universitetshospital0 个研究点目标入组 22 人开始时间: 2008年3月12日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
22

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

  • 1Patients under treatment for AN.
  • 2Patients attending ambulatory treatment, which are not expected to be admitted at the hospital with AN-related pathology or discharged during the study period.
  • 3Patients admitted to Department of Endocrinology M or Psychiatric department P which are not expected to be discharged during the study period.
  • 4Age over 18.
  • 5Duration of the disease over 5 years.
  • 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

  • 1Patients under compulsory treatment or suffering of mania, schizophrenia or primary depression.
  • 2Patients with any medical or psychiatric event related or not related to the underlying eating disorder which requires prolonged admission to the hospital during the study.
  • 3Patients with unstable heart disease (relevant changes in medication prior or during the study) and limitation of activity (not comfortable with more than moderate exertion / at rest).
  • 4Patients not attending to the weekly controls.
  • 5If other severe adverse events (SAE) / drug reactions (SADR) are suspected.
  • 6Patients actually having or having a history of alcohol, cannabis, opioids or central stimulating drugs abuse.
  • 7Patients with known allergy to dronabinol or sesam oil.
  • 8Fertile, menstruating women not using safe contraception*.
  • 9Pregnancy.
  • * - Patients with chronic AN have per definition amenorrhea and seldom vita sexualis.

研究者

发起方
Center for Spiseforstyrrelse, Endokrinologisk Afdeling M, Odense Universitetshospital

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