Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea

PHASE3CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

August 25, 2018

Primary Completion Date

January 8, 2020

Study Completion Date

January 8, 2020

Conditions
Diarrhea, Infantile
Interventions
DRUG

Racecadotril plus ORS

"1.5 mg/kg of Racecadotril will be administered, 3 times daily, via the oral route (in addition to standard treatment i.e. oral rehydration solution).~In infants less than 9 kg: one 10 mg sachet 3 times daily. In infants from 9 kg to \< 13 kg: two 10 mg sachets 3 times daily. In children from 13 kg to 27 kg: one 30 mg sachet 3 times daily. In children of more than 27 kg: two 30 mg sachets 3 times daily."

Trial Locations (2)

Unknown

Linkou Chang Gung Memorial Hospital, Taipei

Mackay Memorial Hospital, Taipei

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abbott

INDUSTRY