Trial Outcomes & Findings for Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea (NCT NCT03463512)

Last Updated: 2019-10-23

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

124 participants

Primary outcome timeframe

5 days

Results posted on

2019-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Racecadotril Plus Standard Treatment Oral Rehydration Solution Racecadotril plus ORS: Racecadotril plus ORS	ORS (Standard Treatment) ORS: ORS
Overall Study STARTED	62	62
Overall Study COMPLETED	62	62
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Racecadotril Plus Standard Treatment Oral Rehydration Solution n=62 Participants Racecadotril plus ORS: Racecadotril plus ORS	ORS (Standard Treatment) n=62 Participants ORS: ORS	Total n=124 Participants Total of all reporting groups
Age, Categorical <=18 years	62 Participants n=5 Participants	62 Participants n=7 Participants	124 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	6.2 years STANDARD_DEVIATION 4.5 • n=5 Participants	6.8 years STANDARD_DEVIATION 4.6 • n=7 Participants	6.5 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	33 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	29 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants	59 Participants n=7 Participants	120 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Russia	62 Participants n=5 Participants	62 Participants n=7 Participants	124 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Population: full analysis sample

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

Outcome measures

Outcome measures
Measure	Racecadotril Plus Standard Treatment Oral Rehydration Solution n=62 Participants Racecadotril plus ORS: Racecadotril plus ORS	ORS (Standard Treatment) n=62 Participants ORS: ORS
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)	20.0 hours Standard Deviation 2.2	43.2 hours Standard Deviation 3.4

SECONDARY outcome

Timeframe: 5 days

Population: full analysis sample

Number of recovered subjects per treatment group. Recovery is defined as the evacuation of the first of two consecutive normal stools or no stool within 12 h within treatment period

Outcome measures

Outcome measures
Measure	Racecadotril Plus Standard Treatment Oral Rehydration Solution n=62 Participants Racecadotril plus ORS: Racecadotril plus ORS	ORS (Standard Treatment) n=62 Participants ORS: ORS
Number of Recovered Subjects Per Treatment Group.	62 Participants	58 Participants

SECONDARY outcome

Timeframe: 5 days

Population: full analysis sample

Globabl physician assessment used 6 scores with a score of 1 or 2 being regarded as treatment success

Outcome measures

Outcome measures
Measure	Racecadotril Plus Standard Treatment Oral Rehydration Solution n=62 Participants Racecadotril plus ORS: Racecadotril plus ORS	ORS (Standard Treatment) n=62 Participants ORS: ORS
Number of Recovered Subjects as Defined by Global Physician Assessment of Success at the End of Treatment	62 Participants	60 Participants

Adverse Events

Racecadotril Plus Standard Treatment Oral Rehydration Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ORS (Standard Treatment)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Suntje Sander

Abbott

Phone: +495116750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place