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

ISRCTN	ISRCTN53730137
DOI	https://doi.org/10.1186/ISRCTN53730137
Protocol serial number	VomED final
Sponsor	University of Leipzig (Germany)
Funder	Hexal - Initiative Kinderarzneimittel (Germany)

Submission date: 30/08/2005
Registration date: 17/10/2005
Last edited: 26/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Holm Uhlig
Scientific

Universitätsklinik und Poliklinik für Kinder und Jugendliche
Universität Leipzig
Oststraße 21-25
Leipzig
04317
Germany

Phone	+49 (0)341 97 26 111
Email	holm.uhlig@medizin.uni-leipzig.de

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Multi-centre
Scientific title
Study acronym	VomED
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Dimenhydrinate suppositories
Primary outcome measure(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 hospitalisation.
Key secondary outcome measure(s)	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
Completion date	30/09/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	5 Years
Sex	All
Target sample size at registration	270
Key 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
Key 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
Date of first enrolment	01/10/2005
Date of final enrolment	30/09/2006

Locations

Countries of recruitment

Germany

Study participating centre

Universitätsklinik und Poliklinik für Kinder und Jugendliche

Leipzig
04317
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2009		Yes	No