Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT03473561
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
60 Months
Study:
NCT03473561
Study Brief:
Protocol Section:
NCT03473561