1)objectives: The present project aims to evaluate efficacy and safety of this drug in acute diarrhea in children under 5-years-old admitted in Mofid pediatric hospital.
2)Design: Not blinded randomized clinical trial in 1-months to 5-years children randomized into either intervention group with Racecadotril or control. There would be 50 cases in each group.
3)Setting and conduct: All eligible cases with the inclusion criteria randomized to intervention or control group.
4)Participants: Children 1-months to 5-years old with no special allergies, no liver or kidney diseases
5)Interventions: hydration therapy (as MANA and WHO protocol) and Racecadotril (1.5 mg per kg three doses a day for 5 days or up to diarrhea discontinues)
6)main outcome measures: duration and frequency of diarrhea and hospital stay days
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607131264N8
Registration date:2017-05-12, 1396/02/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-12, 1396/02/22
Registrant information
Name
Sima Besharat
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1224 4170
Email address
besharat@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of enkefalinase inhibitor racecadotril in decreasing the duration and frequency of acute diarrhea in children 1 months to 5 years
Public title
Efficacy and safety of racecadotril in treatment of acute diarrhea in children 1 months to 5-years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children 1 months to 5 years old; acute diarrhea
Exclusion criteria: children younger than 1 months-old and older than 5 years-old; renal or hepatic failure; history of allergy to any medication
Age
From 1 month old to 5 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Sealed pockets will be used to randomize patients into cases and controls.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Unit of developing clinical research, Mofid hospital
City
Tehran
Postal code
Approval date
2016-05-21, 1395/03/01
Ethics committee reference number
IR.sbmu.rec.1395.1
Health conditions studied
1
Description of health condition studied
acute diarrhea
ICD-10 code
A09.9
ICD-10 code description
Gastroenteritis and colitis of unspecified origin
Primary outcomes
1
Description
duration of diarrhea
Timepoint
days
Method of measurement
medical record
2
Description
frequency of diarrhea
Timepoint
daily
Method of measurement
numbers of defecation in 24 hours
Secondary outcomes
1
Description
duration of hospital stay
Timepoint
days
Method of measurement
medical record
Intervention groups
1
Description
Serum therapy (MANA protocol and WHO guidelines) and Racecadotril (1.5 mg per kg 3 doses in day for 5 days or when no diarrhea)
Category
Treatment - Drugs
2
Description
Only serum therapy
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Mofid Hospital
Full name of responsible person
Dr.Farid Imanzadeh
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Farid Imanzadeh
Street address
Mofid Hospital, Shariati ave., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Farid Imanzadeh
Position
Pediatric gastroentrologist
Other areas of specialty/work
Street address
Mofid Hospital, Shariati ave, Tehran
City
Tehran
Postal code
Phone
+98 21222270218
Fax
Email
drimanzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Farid Imanzadeh
Position
Pediatric gastroentrologist
Other areas of specialty/work
Street address
department of gastroentrology, Mofid pediatric hospital, shariati ave, Tehran city
City
Tehran
Postal code
Phone
+98 21222270218
Fax
Email
drimanzadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahsa Besharat
Position
MD, assistant of pediatrics
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
00
Fax
Email
besharat@goums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)