Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea
Condition: Diarrhea, Infantile
MeSH terms: Diarrhea; Diarrhea, Infantile
Intervention: Racecadotril plus ORS
Intervention description: 1.5 mg/kg of Racecadotril will be administered, 3 times daily, via the oral route (in addition to standard treatment i.e. oral rehydration solution).
In infants less than 9 kg: one 10 mg sachet 3 times daily. In infants from 9 kg to < 13 kg: two 10 mg sachets 3 times daily. In children from 13 kg to 27 kg: one 30 mg sachet 3 times daily. In children of more than 27 kg: two 30 mg sachets 3 times daily.
Intervention MeSH terms: Racecadotril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 3 Months
Maximum age: 60 Months
Healthy volunteers: No

Summary:

      This is a prospective, open-label, multicenter, single-arm study evaluating the efficacy and
      safety of Racecadotril the treatment of children aged 3 to 60 months suffering from acute
      diarrhea
    

Eligibility 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