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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 used to treat acute diarrhea, including diarrhea in infants. It combines racecadotril, a small molecule drug, with oral rehydration salts. Abbott Laboratories is developing this combination, and it has been studied in children aged 3 months and older with acute diarrhea.
Racecadotril plus ORS works because racecadotril is an inhibitor of MME, also known as neprilysin. By inhibiting this enzyme, racecadotril reduces the breakdown of endogenous opioids, which decreases intestinal fluid secretion. The oral rehydration salts component helps replace fluids and electrolytes lost during diarrhea.
Abbott Laboratories, which trades under the ticker ABT, is the developer of racecadotril plus ORS. The company is responsible for the clinical development of this combination therapy for acute diarrhea, including infantile diarrhea.
Racecadotril plus ORS is in Phase 3 clinical development. It is an investigational combination and has not been approved by the FDA. The Phase 3 trials have been completed, and the program is not currently listed as active.
Racecadotril plus ORS has been evaluated in two completed Phase 3 trials. NCT03473561 studied children aged 3 to 60 months with acute diarrhea in Taiwan, enrolling 31 participants. NCT03463512 studied infants, children, and adolescents with acute diarrhea in Russia, enrolling 124 participants.
Racecadotril plus ORS is a combination treatment that includes racecadotril along with oral rehydration salts. Racecadotril is the active pharmacological component, while ORS provides rehydration support. The two are not identical because the combination adds oral rehydration therapy to the racecadotril regimen.