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临床试验/EUCTR2021-002318-15-DK
EUCTR2021-002318-15-DK进行中(未招募)1 期

A pharmacological trial with Sativex® and gentamicin for optimized pharmacological treatment of older patients with a focus on appetite stimulation and renal risk drugs - CanPA

Copenhagen University Hospital, Amager and Hvidovre, Department of Clinical Research0 个研究点目标入组 69 人开始时间: 2021年7月12日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
69

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

  • •Admitted to the Department of Emergency Medicine, Hvidovre Hospital
  • •Can cooperate cognitively
  • •Risk of malnutrition defined by NRS-2002 score =3
  • •Low appetite / age-related anorexia measured with SNAQ score =14
  • •Must be able to read and understand Danish
  • •Postmenopausal defined as missed periods for at least 12 months before the start of the trial
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 69

排除标准

  • •Regular use of medical cannabis (patient reported)
  • •Use of medical cannabis within 14 days at baseline (patient reported)
  • •Recognized or suspected psychotic illness in the subject or his family (medical record and patient report)
  • •Severe personality disorders (journal)
  • •Significant psychiatric disorder in addition to mild to moderate depression (journal)
  • •Allergy to the ingredients of Sativex®, placebo and Hexamycin® (patient reported)
  • •Terminal diagnosis (journal)
  • •Cancer disease (journal)
  • •Liver transplant (journal)
  • •Chronic eGFR =15 mL / min2 or dialysis treatment (journal)
  • •Pacemaker (journal)
  • •Epilepsy (journal)
  • •Recurrent seizures (journal)
  • •Severe cardiovascular disease NYHA IV (journal)
  • •Previous heart attack (journal)
  • •Uncontrolled hypertension (journal)
  • •Cardiac arrhythmias (journal)
  • •Food intolerance to the ingredients in the test meals (patient reported)
  • •Vegetarian and vegan (patient reported)
  • •Unwilling to avoid driving for up to 72 hours after administration of Sativex® (patient-reported)
  • •Unwilling to avoid alcohol 24 hours up to the trial days (patient reported)
  • •Patients with ascites (medical record)
  • •Patients with significant edema on the days of the trial (medical record / visual inspection)

研究者

发起方
Copenhagen University Hospital, Amager and Hvidovre, Department of Clinical Research

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