Infectious enteritis with vomiting MedDRA version: 8.1 Level: PT Classification code 10058839 Term: Enteritis infectious
Conditions
Interventions
Trade Name: Vomacur 40 suppositories
Product Name: Vomacur 40 suppositories
Pharmaceutical Form: Suppository
INN or Proposed INN: Dimenhydrinate
CAS Number: 523-87-5
Concentration unit: mg milligram(s
Sponsors
University of Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acute vomiting started 8-24 hours prior the inclusion due to suggested infectious enteritis with at least 2 episodes of vomiting in the last 12 hours age: 6 months - 5 years weight over 7000g outpatients informed consent of at least one caregiver Are the trial subjects under 18? yes Number of subjects for this age range: 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: Contraindications against the study drug receipts of the following medications: Treatment with medicinal products with suspected interactions with dimenhydrinat, Treatment with antiemetics or secretion inhibitors severe disease with one of the following criteria: bloody stool (with this disease) suggested requirement of i.v. rehydration Confirmed weight loss of more than 5% body weight Metabolic acidosis (i.e. pH < 7,25) and/or electrolyte disturbances (measured by blood test in the emergency clinic originated in the responsibility of the investigator) Suspected lack of cooperation and compliance by the patient or the caregiver(s) or linguistic problems of the parents Participation in other medical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is it possible to reduce dehydration due to vomiting in the initial phase of enteritis with vomiting with Dimenhydrinate suppositories (weight adapted dosage) in comparison to placebo in children. Better rehydration is measured by weight gain in between visit 1 and 2 (visit 2 is 18-24 hours after visit 1);Secondary Objective: Can the number of vomiting episodes between visit 1 and 2 be reduced by dimenhydrinat vs. placebo? Is there a reduction in the number of necessary hospitalisations due to infectious enteritis and vomiting in the study population? Is the condition of the child estimated by their caregivers (measured in a visual scale) improved. Furthermore adverse events and adverse drug reactions will be documented. ;Primary end point(s): Relative weight gain from visit 1 to visit 2 (measured as quartile of the weight at visit 1 in stratified rank). Worst rank will be hospitalization. | — |
Countries
Germany
Outcome results
None listed