Status:
COMPLETED
Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution
Lead Sponsor:
Mead Johnson Nutrition
Conditions:
Gastroenteritis Acute
Eligibility:
All Genders
1-5 years
Phase:
NA
Brief Summary
This is a randomised, controlled, open-label study to determine the clinical effectiveness and safety of a novel ORS compared with a commercial ORS in children 1 to 5 years of age attending emergency ...
Eligibility Criteria
Inclusion
- 1 to 5 years of age, inclusive at randomization
- Hospitalized with mild to moderate dehydration due to ongoing diarrhea
- Signed informed consent obtained for child's participation in the study
Exclusion
- Severe dehydration and/or use of IV fluids for current hospitalization
- Experiencing bloody diarrhea or diarrhea due to Cholera, Dysentery, persistent/chronic diarrhea, diarrhea with severe malnutrition, diarrhea associated with recent antibiotic use
- In the opinion of the Investigator, not suitable for treatment with ORS
- Have any underlying disease or disorder that may, in the opinion of the Investigator, affect the results of the study if they were enrolled (includes, but is not limited to, gastrointestinal disorders such as Crohn's disease or other inflammatory bowel disease or congenital malabsorption disorders)
- Cause of the dehydration is something other than diarrhea
- Known to be allergic to any of the components of the Investigational ORS
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05247879
Start Date
June 30 2022
End Date
January 18 2024
Last Update
March 25 2024
Active Locations (4)
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1
Ramathibodi Hospital
Bangkok, Thailand
2
Siriraj Hospital
Bangkok, Thailand
3
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
4
Naresuan University Hospital
Phitsanulok, Thailand