Clinical Trials List
2018-01-01 - 2020-12-31
Phase III
Terminated3
ICD-10R19.7
Diarrhea, unspecified
ICD-9787.91
Diarrhea
Efficacy and Safety of Racecadotril in the Treatment of Taiwanese Children Aged 3 to 60 Months Suffering From Acute Diarrhea: A Prospective, Open-label, Multicenter, Single-arm Study.
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Trial Applicant
QPS
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Sponsor
Abbott
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Nan-Chang Chiu Division of Pediatrics
- 李宏昌 Division of Pediatrics
- Chi Hsin Division of Pediatrics
- 江椿彬 Division of Pediatrics
- 陳偉燾 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 郭貞孍 Division of Pediatrics
- 楊長佑 Division of Pediatrics
- 李嶸 Division of Pediatrics
- 葉宏瑀 Division of Pediatrics
- 吳昌騰 Division of Pediatrics
- 趙舜卿 Division of Pediatrics
- 朱世明 Division of Pediatrics
- 許凱翔 Division of Pediatrics
- 傅仁煇 Division of Pediatrics
- Ming-Wei Lai Division of Pediatrics
- 李建忠 Division of Pediatrics
- 林瑞瑩 Division of Pediatrics
- 江明洲 Division of Pediatrics
- 陳建彰 Division of Pediatrics
- Jen Fu Hsu Division of Pediatrics
- 賴美吟 Division of Pediatrics
- 吳怡萱 Division of Pediatrics
The Actual Total Number of Participants Enrolled
21 Terminated
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
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 [ Time Frame: 5 days ]
Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary
Secondary Outcome Measures :
Number of recovered subjects [ Time Frame: 5 days ]
Number of recovered subjects
Global Physician Assessment at the end of treatment [ Time Frame: 5 days ]
scores 1-6
Inclution 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
The Estimated Number of Participants
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Taiwan
48 participants
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Global
48 participants
