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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	CTRI
Last refreshed on:	24 November 2021
Main ID:	CTRI/2013/01/003333
Date of registration:	28-01-2013
Prospective Registration:	No
Primary sponsor:	Sanofi Synthelabo India Limited
Public title:	An observational registry to evaluate the current clinical practice on the management of diarrhea in children
Scientific title:	Registry in the management of acute diarrhea in children: observational study in daily practice. - REMAD 2
Date of first enrolment:	01-01-2013
Target sample size:	3750
Recruitment status:	Closed to Recruitment of Participants
URL:	http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5416
Study type:	Observational
Study design:	Other Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
Phase:	N/A

Countries of recruitment
Bangladesh	Costa Rica	Dominican Republic	Egypt	El Salvador	Georgia	Guatemala	Honduras
India	Jordan	Kazakhstan	Kuwait	Lebanon	Mexico	Pakistan	Panama
Qatar	Saudi Arabia	United Arab Emirates	Uzbekistan	Venezuela (Bolivarian Republic of)

Contacts

Name:	Ms Gayatri Jaiswal
Address:	A-101, Business Square, Sir Mathuradas Vasanji Marg, Chakala, Andheri (E), 400093 Mumbai, MAHARASHTRA India
Telephone:	02230707806
Email:	Gayatri.Jaiswal@sanofi.com
Affiliation:	Sanofi Synthelabo India Limited

Name:	Ms Gayatri Jaiswal
Address:	A-101, Business Square, Sir Mathuradas Vasanji Marg, Chakala, Andheri (E), 400093 Mumbai, MAHARASHTRA India
Telephone:	02230707806
Email:	Gayatri.Jaiswal@sanofi.com
Affiliation:	Sanofi Synthelabo India Limited

Key inclusion & exclusion criteria

Inclusion criteria: •Infants or children presenting with acute diarrhea acquired in the community,

• Aged between 6 months to 6 years old,

• Children with acute diarrhea evident for less than 48 hours whatever the origin,

• Children who had >= 3 watery stools during the preceding 24 hours,

• Children whose parents or legal guardians have given their written informed

consent.
Exclusion criteria: Children suffering from a chronic disease [Crohnâ??s Disease, Hemorrhagic rectocolitis,

IBS),

• Parents or legal guardians unable to fill diary card.

• Children suffering from severe malnutrition and/or immuno-compromised

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Childhood acute diarrhea. Health Condition 2: R197- Diarrhea, unspecified

Intervention(s)

Primary Outcome(s)

To describe the current â??real lifeâ?? management of childhood acute diarrhea in developing countries/regions.

Timepoint: At the time of end of the study

Secondary Outcome(s)

To country/local specificities that may determine some therapeutic decisions /

o Type of center,

o Medication availability/cost,

o Laboratory tests,

o Traditions,

o Geographical constrainsâ?¦.

2. To generate epidemiological data on the different types of diarrhea in these countries/regions.

Timepoint: At the time of end of the study

Secondary ID(s)

DIREGR06373 Protocol Final version 1-Dated 5-Jun-2012

Source(s) of Monetary Support

Sanofi Synthelabo (India) Limited

Secondary Sponsor(s)

Ethics review