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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Watery Diarrhea

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
December 6, 2021
Last Updated
January 21, 2022
Sponsor
Assiut University
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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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