Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea
Condition: Diarrhea
MeSH terms: Diarrhea
Intervention: Racecadotril plus ORS; ORS
Intervention description: Racecadotril plus ORS; ORS
Intervention MeSH terms: Racecadotril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 3 Months
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Multicenter, open-label, controlled, randomized clinical study to evaluate the efficacy and
      safety of Racecadotril in infants, children and adolescents with acute diarrhea
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent from one of the parent(s)/caregiver(s) or subject informed
             assent

          -  Children and adolescents, both genders, age from 3 months to < 18 years of age

          -  Confirmed diagnosis of acute diarrhea (defined as the passage of three or more
             unformed or liquid stools within the last 24 hours and lasting for less than three
             days)

          -  Females of child-bearing potential should agree to continue using a medically
             acceptable method of birth control throughout the study and for 30 days immediately
             after the last dose of study drug. Medically acceptable methods of birth control
             include bilateral tubal ligation or the use of either a contraceptive implant, a
             contraceptive injection, an intrauterine device, or an oral contraceptive taken within
             the past three months where the subject agrees to continue using during the study or
             to adopt another birth control method, or a double-barrier method which consists of a
             combination of any two of the following: diaphragm, cervical cap, condom, or
             spermicide

        Exclusion Criteria:

          -  Known allergy to Racecadotril or any of its ingredients

          -  Subjects suffering from renal or hepatic impairment

          -  Subjects who need treatment for diarrhea other than ORS alone

          -  Subjects with fever > 39 degrees Celsius

          -  Subjects with bloody and/or purulent stools

          -  Subjects suffering from antibiotic-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, inflammatory 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 or galactose intolerance, Lapp
             lactase deficiency, glucose-galactose malabsorption syndrome or sucrase isomaltase
             insufficiency or primary or secondary lactase insufficiency

          -  Subjects having received antibiotic treatment at any time within 30 days prior to
             inclusion into the study

          -  Subjects having received antidiarrheal drugs 48 hours prior to inclusion into the
             study

          -  Subjects with severe dehydration required for intravenous/parenteral rehydration

          -  Subjects who have 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 depending in the judgment of the investigator

          -  Intake of experimental drug within 30 days prior to study start

          -  Subjects with contraindications to ORS or for whom warnings/precautions of ORS apply

          -  Adolescents (≥ 60 kg) not able to swallow capsules

          -  Pregnancy and lactation