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临床试验/EUCTR2014-004282-25-FR
EUCTR2014-004282-25-FR进行中(未招募)1 期

Subcutaneous route and pharmacology of metoclopramide - SOPHA-Méto - SOPHA-Meto

CHU de Bordeaux0 个研究点目标入组 24 人开始时间: 2015年6月25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
24

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

入选标准

  • - Man or woman aged at least 18 years
  • - Patient hospitalized at the University Hospital of Bordeaux on palliative department
  • - Patients with life expectancy estimated by the investigator, is greater than 3 weeks
  • - Patients suffering from nausea the day of inclusion with a score greater than or equal to 3/10 on a numerical scale and / or had at least one vomiting within three days prior to inclusion
  • - Patient can be infused IV and SC
  • - Patient can communicate verbally or in writing
  • - Patient has given its written consent
  • 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 18
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 6

排除标准

  • - Pregnant or breastfeeding women
  • - Current treatment for severe and progressive threatening disease
  • - Treatment with oral or injectable metoclopramide within 3 days prior to inclusion
  • - Current Treatment with levodopa or dopamine agonists
  • - Neuroleptic Processing
  • - Presence of clinical signs of encephalopathy (flapping, drowsiness, disorientation)
  • - Patient achieved a lesion occlusive syndrome according to the investigator,
  • - Patients at risk of gastrointestinal perforation according to the investigator
  • - Patient with clinical signs of gastrointestinal bleeding
  • - Patient with dyskinesia
  • - Patient with an extra-pyramidal syndrome
  • - Known or suspected patients with pheochromocytoma
  • - History of allergy to metoclopramide
  • - History of methemoglobinemia with metoclopramide
  • - History deficit NADH-cytochrome b5 reductase-
  • - Patient deprived of liberty by judicial or administrative decision
  • - Major protected by law
  • - Patient exclusion period relative over another protocol.

研究者

发起方
CHU de Bordeaux

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