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 stomach flu and concomitant vomiting

Phase 1

Active, not recruiting

Conditions: Gastroenteritis
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2016-003582-25-NL

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.