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

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy and Safety of Racecadotril in the treatment of children aged 3 to 60 months suffering from acute diarrhea: An open-label study

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Racecadotril; Thiorphan

Criteria

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