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ISRCTN
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ISRCTN53730137
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ClinicalTrials.gov identifier
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Public title
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Doubleblind randomised multicenter trial to investigate the influence of dimenhydrinate suppositories versus placebo on oral rehydration in infants and children with infectious enteritis and vomiting
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Scientific title
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Acronym
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VomED
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Serial number at source
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VomED final
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Study hypothesis
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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).
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Infectious enteritis with vomiting
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/10/2005
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Anticipated end date
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30/09/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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270
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Interventions
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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).
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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Sources of funding
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Hexal - Initiative Kinderarzneimittel (Germany)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19752076
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Contact name
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Dr
Holm
Uhlig
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Address
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Universitätsklinik und Poliklinik für Kinder und Jugendliche
Universität Leipzig
Oststraße 21-25
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City/town
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Leipzig
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Zip/Postcode
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04317
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Country
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Germany
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Tel
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+49 (0)341 97 26 111
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Fax
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+49 (0)341 97 26 279
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Email
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holm.uhlig@medizin.uni-leipzig.de
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Sponsor
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University of Leipzig (Germany)
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Address
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Ritterstraße 26
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City/town
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Leipzig
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Zip/Postcode
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04109
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Country
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Germany
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Date applied
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30/08/2005
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Last edited
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26/10/2009
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Date ISRCTN assigned
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17/10/2005
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