Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea (NCT NCT03473561)

NCT ID: NCT03473561

Last Updated: 2023-11-24

Results Overview

Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 31 participants
• Primary outcome timeframe: 5 days
• Results posted on: 2023-11-24

Participant Flow

Participant milestones

Measure	Racecadotril Plus Standard Treatment Oral Rehydration Solution 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) 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.
Overall Study STARTED	31
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Racecadotril Plus Standard Treatment Oral Rehydration Solution n=31 Participants 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) 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.
Age, Categorical <=18 years	31 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	18 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	31 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment Taiwan	31 Participants n=93 Participants

PRIMARY outcome

Timeframe: 5 days

Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary

Outcome measures

Measure

Racecadotril Plus Standard Treatment Oral Rehydration Solution n=31 Participants 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) 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.

Duration of Diarrhea (Hours) Between the Start of Treatment Until Last Diarrheal/Watery Stool Before Recovery or End of Study Treatment (Treatment Duration Maximal 5 Days

57.5 hours Standard Error 5.79

SECONDARY outcome

Timeframe: 5 days

Population: FA Sample

Number of recovered subjects

Outcome measures

Measure

Racecadotril Plus Standard Treatment Oral Rehydration Solution n=31 Participants 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) 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.

Number of Recovered Subjects

23 Participants

SECONDARY outcome

Timeframe: 5 days

Scores 1-6 (Scores 1 and 2 are defined as success)

Outcome measures

Measure

Racecadotril Plus Standard Treatment Oral Rehydration Solution n=31 Participants 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) 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.

Global Physician Assessment at the End of Treatment

25 Participants

Adverse Events

Racecadotril Plus Standard Treatment Oral Rehydration Solution

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure

Racecadotril Plus Standard Treatment Oral Rehydration Solution n=31 participants at risk 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) 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.

Infections and infestations Bronchitis

3.2% 1/31 • 5 days plus 1 gap day

Other adverse events

Measure	Racecadotril Plus Standard Treatment Oral Rehydration Solution n=31 participants at risk 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) 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.
Gastrointestinal disorders Diarrhoea	9.7% 3/31 • 5 days plus 1 gap day
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	22.6% 7/31 • 5 days plus 1 gap day
Respiratory, thoracic and mediastinal disorders Laryngitis	6.5% 2/31 • 5 days plus 1 gap day
Respiratory, thoracic and mediastinal disorders Bronchiolitis	6.5% 2/31 • 5 days plus 1 gap day
Skin and subcutaneous tissue disorders Dermatitis	6.5% 2/31 • 5 days plus 1 gap day

Additional Information

Suntje Sander, PhD

Abbott Laboratories

Phone: 0049 - 511 - 6750 3254

Email: suntje.sander@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place