Virus caused vomiting and effect of the antiemetic drug Ondansetron
Conditions
Interventions
Trade Name: Zofran (Ondansetron)
Product Name: Zofran
Pharmaceutical Form: Oral solution
INN or Proposed INN: ONDANSETRON
CAS Number: 116002-70-1
Other descriptive name: Zofran
Concentration unit: mg/
Sponsors
Lennart Svensson Linköping University Medical Faculty
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate if Ondansetron can reduce vomiting in virus caused gastroenteritis. ;Secondary Objective: To favor treatment with oral rehydration therapy. ;Primary end point(s): The patient is monitored for vomiting and diarrhea for 24 hours after treatment with ondansetron (1 dose). The the clinical trial for each patient is ended when a person from the study team has make an phone call for the 24-h follow-up. The phone call is between 24 to 72 hours after treatment.;Timepoint(s) of evaluation of this end point: At 24-72 hours after the Ondansetron/placebo dose, a person from the study team will give a phone call to obtain information about the patients condition, the numbers of vomiting, the number of diarrhea episodes and eventually side-effects. It is 24h follow-up after oral intake of ondansetron/placebo. After the phone call is finished the clinical trial is ended. | — |
Countries
Sweden
Contacts
Public ContactClinical trial Information
Lennart Svensson
Outcome results
None listed