Contact information
Type
Scientific
Primary contact
Dr Holm Uhlig
ORCID ID
Contact details
Universitätsklinik und Poliklinik für Kinder und Jugendliche
Universität Leipzig
Oststraße 21-25
Leipzig
04317
Germany
+49 (0)341 97 26 111
holm.uhlig@medizin.uni-leipzig.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
VomED final
Study information
Scientific title
Acronym
VomED
Study hypothesis
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).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Infectious enteritis with vomiting
Intervention
Treatment with Dimenhydrinate or Placebo in the following dosage:
7-15 kg body weight: 1-2 Supp at 40 mg/24 hours
15-25 kg body weight: 2-3 Supp at 40 mg/24 hours
>25 kg body weight: 2-4 Supp at 40 mg/24 hours
Treatment for the individual patient: 18-24 hours (from visit 1 to visit 2).
Intervention type
Drug
Phase
Not Specified
Drug names
Dimenhydrinate suppositories
Primary outcome measures
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 hospitalisation.
Secondary outcome measures
1. Can the number of vomiting episodes between visit 1 and 2 be reduced by dimenhydrinate versus placebo?
2. Is there a reduction in the number of necessary hospitalisations due to infectious enteritis and vomiting in the study population?
3. Is the condition of the child estimated by their caregivers (measured in a visual scale) improved?
4. Furthermore adverse events and adverse drug reactions will be documented
Overall trial start date
01/10/2005
Overall trial end date
30/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Acute vomiting started 8-24 hours prior to the inclusion due to suggested infectious enteritis with at least 2 episodes of vomiting in the last 12 hours
2. Age: 6 months-5 years
3. Weight over 7,000 g
4. Outpatients
5. Informed consent of at least one caregiver
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
270
Participant exclusion criteria
1. Contraindications against the study drug
2. Receipt of the following medications:
2.1. Treatment with medicinal products with suspected interactions with dimenhydrinate
2.2. Treatment with antiemetics or secretion inhibitors
3. Severe disease with one of the following criteria:
3.1. Bloody stool with this disease
3.2. Suggested requirement of intravenous (IV) rehydration
3.3. Confirmed weight loss of more than 7.5% body weight
3.4. 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)
4. Suspected lack of cooperation and compliance by the patient or the caregiver(s) or linguistic problems of the parents
5. Participation in other medical trials
Recruitment start date
01/10/2005
Recruitment end date
30/09/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Universitätsklinik und Poliklinik für Kinder und Jugendliche
Leipzig
04317
Germany
Funders
Funder type
Industry
Funder name
Hexal - Initiative Kinderarzneimittel (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19752076
Publication citations
-
Results
Uhlig U, Pfeil N, Gelbrich G, Spranger C, Syrbe S, Huegle B, Teichmann B, Kapellen T, Houben P, Kiess W, Uhlig HH, Dimenhydrinate in children with infectious gastroenteritis: a prospective, RCT., Pediatrics, 2009, 124, 4, e622-32, doi: 10.1542/peds.2008-1650.