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

Completed

• Conditions: Infectious enteritis with vomiting; Infections and Infestations; Other bacterial intestinal infections

• Registration Number: ISRCTN53730137
• Lead Sponsor: niversity of Leipzig (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 270

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified