Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea

Inclusion Criteria

• Signed informed consent from one of the parent(s)/legal representative(s)
• Subjects, both genders, aged 3 to 60 months
• Subjects with acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than 3 days)

Exclusion Criteria

• Known allergy to Racecadotril or any of its ingredients
• Subjects suffering from renal or hepatic impairment
• Subjects with fever > 39 degrees Celsius
• Subjects with bloody and/or purulent stools
• Subjects suffering from antibiotic (e.g. amoxicillin)-associated diarrhea, chronic diarrhea or iatrogenic diarrhea
• Subjects with alternating bouts of diarrhea and constipation
• Diarrhea due to exacerbation of chronic gastrointestinal diseases such as irritable bowel syndrome, irritable bowel disease or pancreatic exocrine insufficiency
• Cystic fibrosis or coeliac disease
• Subjects suffering from prolonged or uncontrolled vomiting
• Subjects with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency
• Subjects having received antibiotic treatment at any time within 2 weeks prior to inclusion into the study
• Subjects having received antidiarrheal drugs 48 hours prior to inclusion into the study
• Subjects with severe dehydration requiring intravenous fluid, electrolyte replacement or hospitalization treatment
• Subject with a history of angioedema or who had reported angioedema with angiotensin converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril)
• Subjects with combined diseases or medical situations that would prevent to be enrolled into the study, depending on the judgment of the investigator
• Intake of experimental drug within 30 days prior to study start
• Subjects with contraindications to ORS or susceptible to the warnings of ORS