EUCTR2016-003582-25-NL进行中（未招募）1 期
The added effect of oral ondansetron to care-as-usual on persistingvomiting in children aged 6 months to 6 years, presenting at primary careout of hours service with acute gastro-enteritis and concomitant vomiting - COOKING
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •1. Aged 6 months to 6 years;
- •2. At least four reported episodes of vomiting or diarrhoea during the
- •last twenty-four hours preceding presentation
- •3. At least one reported episode of vomiting within the four hours
- •preceding presentation;
- •4. Diagnosed with AGE by a general practitioner at the OHS.
- •5. Parental written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 220
- •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
- •1. Aged 6 months to 6 years;
- •2. At least four reported episodes of vomiting or diarrhoea during the
- •last twenty-four hours preceding presentation
- •3. At least one reported episode of vomiting within the four hours
- •preceding presentation;
- •4. Diagnosed with AGE by a general practitioner at the OHS.
- •5. Parental written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 220
- •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
- •1. Aged 6 months to 6 years;
- •2. At least four reported episodes of vomiting or diarrhoea during the
- •last twenty-four hours preceding presentation
- •3. At least one reported episode of vomiting within the four hours
- •preceding presentation;
- •4. Diagnosed with AGE by a general practitioner at the OHS.
- •5. Parental written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 220
- •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
- •1. Use of anti-emetics in the previous 6 hours;
- •2. Known renal failure or hypoalbuminemia (as this could affect the
- •assessment of hydration status);
- •3. Known diabetes mellitus or inflammatory bowel disease (as this
- •could increase the risk of a complicated course);
- •4. A history of abdominal surgery, with suspected recurrence of original
- •abdominal symptoms or strangulation ileus explaining current
- •symptoms, according to the general practitioner.
- •5. Known sensitivity to 5-HT3 receptor antagonists;
- •6. Known prolonged QT interval;
- •7. Current use of QT prolonging medication;
- •8. Previous enrolment in the study.
- •1. Use of anti-emetics in the previous 6 hours;
- •2. Known renal failure or hypoalbuminemia (as this could affect the
- •assessment of hydration status);
- •3. Known diabetes mellitus or inflammatory bowel disease (as this
- •could increase the risk of a complicated course);
- •4. A history of abdominal surgery, with suspected recurrence of original
- •abdominal symptoms or strangulation ileus explaining current
- •symptoms, according to the general practitioner.
- •5. Known sensitivity to 5-HT3 receptor antagonists;
- •6. Known prolonged QT interval;
- •7. Current use of QT prolonging medication;
- •8. Previous enrolment in the study.
- •1. Use of anti-emetics in the previous 6 hours;
- •2. Known renal failure or hypoalbuminemia (as this could affect the
- •assessment of hydration status);
- •3. Known diabetes mellitus or inflammatory bowel disease (as this
- •could increase the risk of a complicated course);
- •4. A history of abdominal surgery, with suspected recurrence of original
- •abdominal symptoms or strangulation ileus explaining current
- •symptoms, according to the general practitioner.
- •5. Known sensitivity to 5-HT3 receptor antagonists;
- •6. Known prolonged QT interval;
- •7. Current use of QT prolonging medication;
- •8. Previous enrolment in the study.
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