Phase 3
N=124
Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea
Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT03463512 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: 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) — 20.0; 43.2 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Racecadotril plus ORS (Drug); ORS (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Sep 2018
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) |
20.0; 43.2 | — |
| SECONDARY Number of Recovered Subjects Per Treatment Group. |
62; 58 | — |
| SECONDARY Number of Recovered Subjects as Defined by Global Physician Assessment of Success at the End of Treatment |
62; 60 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT03463512). 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.