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
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