Anti-Secretory Drug in Treatment of Acute Watery Diarrhea
Primary Purpose
Acute Watery Diarrhea
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Racecadotril
Sponsored by
About this trial
This is an interventional treatment trial for Acute Watery Diarrhea
Eligibility Criteria
Inclusion Criteria:
- Age group for six months - 5 years.
- No or mild to moderate dehydration.
- Alert patient (to tolerate oral intake since the drug is only available in oral form).
Exclusion Criteria:
- Patients with severe dehydration (inability to drink because of drowsiness).
- Patients with any serious concomitant illness that needs antibiotic treatment.
- If severe adverse events occur at any time.
- Chronic diarrhea.
Sites / Locations
- Assiut University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
children received ORS and racecadotril as treatment
children received ORS alone as treatment
Arm Description
25 children received ORS and racecadotril as treatment (at a dose of 1.5 mg/kg/day, an oral single daily dose for three days)
25 children received ORS alone for treatment as a control group
Outcomes
Primary Outcome Measures
Diarrheal episode
number
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05216822
Brief Title
Anti-Secretory Drug in Treatment of Acute Watery Diarrhea
Official Title
Role of Anti-Secretory Drug in Treatment of Children With Acute Watery Diarrhea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In conclusion, racecadotril is an anti-secretory drug that exerts its antidiarrheal effect by inhibiting intestinal enkephalinase. It is effective in reducing the volume and frequency of stool output. racecadotril is well tolerated and safe by providing symptomatic relief and reducing the severity of diarrhea as an adjuvant therapy during the acute attack of gastroenteritis. It is recommended that the new generations of already discovered drugs for control of secretory diarrhea should be studied to discover the ones with fewer side effects to other systems in the body.
Detailed Description
Background: Previous studies have shown that racecadotril is a safe and effective drug in treating children with acute diarrhea. Study Aim: to evaluate the effect of racecadotril as an adjunct to oral rehydration solution in the treatment of acute watery diarrhea among children under 5 years of age. Subjects and methods: This RCT trial included 50 children with acute watery diarrhea for 5 days or less with a frequency of three or more diarrheic stools in the past 24 hours before admission to the hospital, with no/mild to moderate dehydration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Watery Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
children received ORS and racecadotril as treatment
Arm Type
Experimental
Arm Description
25 children received ORS and racecadotril as treatment (at a dose of 1.5 mg/kg/day, an oral single daily dose for three days)
Arm Title
children received ORS alone as treatment
Arm Type
Active Comparator
Arm Description
25 children received ORS alone for treatment as a control group
Intervention Type
Drug
Intervention Name(s)
Racecadotril
Other Intervention Name(s)
Acetorphan
Intervention Description
racecadotril (dose of 1.5 mg/kg/day, an oral single daily dose for three days
Primary Outcome Measure Information:
Title
Diarrheal episode
Description
number
Time Frame
1-3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age group for six months - 5 years.
No or mild to moderate dehydration.
Alert patient (to tolerate oral intake since the drug is only available in oral form).
Exclusion Criteria:
Patients with severe dehydration (inability to drink because of drowsiness).
Patients with any serious concomitant illness that needs antibiotic treatment.
If severe adverse events occur at any time.
Chronic diarrhea.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamada M Kamel, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Asyut
ZIP/Postal Code
71511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Anti-Secretory Drug in Treatment of Acute Watery Diarrhea
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