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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05216822
Other study ID # IRB-2/2019AZA
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 1, 2018
Est. completion date August 31, 2018

Study information

Verified date January 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Months to 5 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Racecadotril
racecadotril (dose of 1.5 mg/kg/day, an oral single daily dose for three days

Locations

Country Name City State
Egypt Assiut University Asyut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diarrheal episode number 1-3 months
See also
  Status Clinical Trial Phase
Terminated NCT01618591 - Trial Evaluating Ambulatory Treatment of Travelers' Diarrhea N/A