EUCTR2005-003943-30-DE进行中（未招募）1 期
Doubleblind randomized multicenter trial to investigate the influence of dimenhydrinate suppositories vs. placebo on oral rehydration in infants and children with infectious enteritis and vomiting - VomED
niversity of Leipzig0 个研究点目标入组 270 人开始时间: 2006年5月5日最近更新:
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
- 270
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
- •Acute vomiting started 8-24 hours prior the inclusion due to suggested infectious enteritis with at least 2 episodes of vomiting in the last 12 hours
- •age: 6 months - 5 years
- •weight over 7000g
- •outpatients
- •informed consent of at least one caregiver
- •Are the trial subjects under 18? yes
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Contraindications against the study drug
- •receipts of the following medications:
- •Treatment with medicinal products with suspected interactions with dimenhydrinat,
- •Treatment with antiemetics or secretion inhibitors
- •severe disease with one of the following criteria:
- •bloody stool (with this disease)
- •suggested requirement of i.v. rehydration
- •Confirmed weight loss of more than 5% body weight
- •Metabolic acidosis (i.e. pH < 7,25) and/or electrolyte disturbances (measured by blood test in the emergency clinic originated in the responsibility of the investigator)
- •Suspected lack of cooperation and compliance by the patient or the caregiver(s) or linguistic problems of the parents
- •Participation in other medical trials
研究者
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