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Racecadotril plus ORS · 2 trials · 2 indications
Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary
Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary. Log-rank test was performed with a p-value \< 0.0001
| Arm | Type | Description |
|---|---|---|
| Racecadotril plus standard treatment oral rehydration solution | EXPERIMENTAL | Racecadotril Infants Granules for Oral Suspension 10 mg (in addition to standard treatment i.e. oral rehydration solution) Racecadotril Children Granules for Oral Suspension 30 mg (in addition to standard treatment i.e. oral rehydration solution) |
| ORS (standard treatment) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Racecadotril plus ORS | DRUG | 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. |
| ORS | DRUG | ORS |
Inclusion Criteria: * Signed informed consent from one of the parent(s)/legal representative(s) * Subjects, both genders, aged 3 to 60 months * Subjects with acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than 3 days) ...
Racecadotril plus ORS is an investigational small molecule being studied for the treatment of acute diarrhea in infants, children, and adolescents. It is being evaluated in pediatric populations aged 3 months and older with conditions including diarrhea and infantile diarrhea. The drug is currently in Phase 3 clinical development.
Racecadotril plus ORS is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. The developer is responsible for advancing this investigational therapy through clinical trials for the treatment of acute diarrhea in pediatric patients.
Racecadotril plus ORS is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its efficacy and safety for the treatment of acute diarrhea in infants, children, and adolescents.
Racecadotril plus ORS has been studied in two completed Phase 3 clinical trials. NCT03463512 evaluated the drug in 124 participants with diarrhea in Russia, while NCT03473561 studied it in 31 children aged 3 to 60 months with infantile diarrhea in Taiwan. Both trials are completed.
Racecadotril plus ORS is a small molecule that combines racecadotril, an enkephalinase inhibitor, with oral rehydration salts. By inhibiting enkephalinase, it reduces intestinal fluid secretion, helping to manage diarrhea. The oral rehydration salts help replace lost fluids and electrolytes.