Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea
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Layout table for eligibility information
Ages Eligible for Study:
3 Months to 60 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
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