NCT05216822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

December 6, 2021

Last Update Submit

January 21, 2022

Conditions

Acute Watery Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Diarrheal episode

    number

    1-3 months

Study Arms (2)

children received ORS and racecadotril as treatment

EXPERIMENTAL

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)

Drug: Racecadotril

children received ORS alone as treatment

ACTIVE COMPARATOR

25 children received ORS alone for treatment as a control group

Drug: Racecadotril

Interventions

RacecadotrilDRUG

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

Also known as: Acetorphan
children received ORS alone as treatmentchildren received ORS and racecadotril as treatment

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71511, Egypt

Location

MeSH Terms

Interventions

racecadotril

Study Officials

  • Hamada M Kamel, MD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 6, 2021

First Posted

February 1, 2022

Study Start

June 1, 2018

Primary Completion

July 31, 2018

Study Completion

August 31, 2018

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)