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
Secondary identifying numbers	VomED final

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Multi-centre
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dimenhydrinate suppositories
Primary outcome measure	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 study start date	01/10/2005
Completion date	30/09/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	5 Years
Sex	Both
Target number of participants	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

Sponsor information

University of Leipzig (Germany)
University/education

Ritterstraße 26
Leipzig
04109
Germany

"ROR"	https://ror.org/03s7gtk40

Funders

Funder type

Industry

Hexal - Initiative Kinderarzneimittel (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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