Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea
Lead Sponsor:
Abbott
Conditions:
Diarrhea, Infantile
Eligibility:
All Genders
3-60 years
Phase:
PHASE3
Brief 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
Detailed Description
Subjects presenting with acute diarrhea will be evaluated for eligibility. If eligible, demographics, number of stools during the last 12 hours will be assessed as baseline values. On Day 1, the subje...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03473561
Start Date
August 25 2018
End Date
January 8 2020
Last Update
November 24 2023
Active Locations (2)
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1
Linkou Chang Gung Memorial Hospital
Taipei, Taiwan
2
Mackay Memorial Hospital
Taipei, Taiwan