Phase 3
Completed N=31
Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea
Diarrhea, Infantile
Source: ClinicalTrials.gov NCT03473561 ↗
Enrolled (actual)
31
Serious AEs
3.2%
Results posted
Nov 2023
Primary outcomePrimary: Duration of Diarrhea (Hours) Between the Start of Treatment Until Last Diarrheal/Watery Stool Before Recovery or End of Study Treatment (Treatment Duration Maximal 5 Days — 57.5 hours
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Diarrhea (Hours) Between the Start of Treatment Until Last Diarrheal/Watery Stool Before Recovery or End of Study Treatment (Treatment Duration Maximal 5 Days |
57.5 | — |
| SECONDARY Number of Recovered Subjects |
23 | — |
| SECONDARY Global Physician Assessment at the End of Treatment |
25 | — |
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
Data sourced from ClinicalTrials.gov (NCT03473561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.