Gastroenteritis
Conditions
Interventions
Trade Name: Ondansetron
Product Name: Ondansetron
Product Code: RVG 31839
Pharmaceutical Form: Syrup
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
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 ;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 ;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
Exclusion criteria
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. ;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. ;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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the added effect of oral ondansetron to care-as-usual (including ORT) (CAU) on persisting vomiting within the first 4 hours after presentation at an out-of-hours primary care service (OHS) in children aged 6 months to 6 years with acute gastroenteritis.;Secondary Objective: Moreover, we intend to evaluate the predictive value of patient characteristics and symptoms for the risk of dehydration in a population of children at risk for dehydration.;Primary end point(s): The number of children with persisting vomiting during the first 4 hours after inclusion.;Timepoint(s) of evaluation of this end point: We will evaluate the primary endpoint when the study ends (estimated in 2018);Main Objective: The primary objective is to determine the added effect of oral ondansetron to care-as-usual (including ORT) (CAU) on persisting vomiting within the first 4 hours after presentation at an out-of-hours primary care service (OHS) in children aged 6 months to 6 years with acute gastroenteritis.;Secondary Objective: Moreover, we intend to evaluate the predictive value of patient characteristics and symptoms for the risk of dehydration in a population of children at risk for dehydration.;Primary end point(s): The number of children with persisting vomiting during the first 4 hours after inclusion.;Timepoint(s) of evaluation of this end point: We will evaluate the primary endpoint when the study ends (estimated in 2018);Main Objective: The primary objective is to determine the added effect of oral ondansetron to care-as-usual (including ORT) (CAU) on persisting vomiting within the first 4 hours after presentation at an out-of-hours primary care service (OHS) in children aged 6 months to 6 years with acute gastroenteritis.;Secondary Objective: Moreover, we intend to evaluate the predictive value of patient characteristics and symptoms for the risk of dehydration in a population of children at risk for dehydration.;Primary end point(s | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cessation of vomiting, the number of vomiting episodes during ORT, referral rate, the proportion that required intravenous rehydration, the proportion hospitalization, quality of life and healthcare use and costs;Timepoint(s) of evaluation of this end point: We will evaluate the primary endpoint when the study ends (estimated in 2018);Secondary end point(s): Cessation of vomiting, the number of vomiting episodes during ORT, referral rate, the proportion that required intravenous rehydration, the proportion hospitalization, quality of life and healthcare use and costs;Timepoint(s) of evaluation of this end point: We will evaluate the primary endpoint when the study ends (estimated in 2018);Secondary end point(s): Cessation of vomiting, the number of vomiting episodes during ORT, referral rate, the proportion that required intravenous rehydration, the proportion hospitalization, quality of life and healthcare use and costs;Timepoint(s) of evaluation of this end point: We will evaluate the primary endpoint when the study ends (estimated in 2018) | — |
Countries
Netherlands
Contacts
Public ContactDepartment of General Practice;Department of General Practice;Department of General Practice ;;
University Medical Center Groningen;University Medical Center Groningen;University Medical Center Groningen
Outcome results
None listed