Can 5-HT3 receptor antagonists be used to limit vomiting in rota- and norovirus infections?
- Conditions
- Virus caused vomiting and effect of the antiemetic drug OndansetronTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-005700-15-SE
- Lead Sponsor
- ennart Svensson Linköping University Medical Faculty
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion criteria are: Children who have vomited (not blood, not bile and not feaces) at least once during the last four hours and had at least one non-bloody diarrhea during the illness period, and most have a mild to moderate dehydration should be included in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 215
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 are: severe dehydration or other disease that may obscure the assessment of dehydreringsgraden (renal failure or hypoabluminemi), formerly Ondansetron allergy, previous abdominal surgery, fructose intolerance, use of antiemetics during the last 72 hours, and previous participation in the study. Other exclusion criteria are severe congenital heart defects, immune deficiency, malignancy, malnutrition, cystic fibrosis, sickle cell anemia, diabetes mellitus and features suggestive of a disease other than gastroenteritis on medical examination (such as focal neurological signs or signs of increased intracranial pressure, acute abdominal surgical condition and supraventricular tachycardia).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method