Condition category
Infections and Infestations
Date applied
30/08/2005
Date assigned
17/10/2005
Last edited
26/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University of Leipzig (Germany)

Sponsor details

Ritterstraße 26
Leipzig
04109
Germany

Sponsor type

University/education

Website

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

  1. 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.

Additional files

Editorial Notes