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

Primary Purpose

Diarrhea, Infantile

Status

Completed

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

Racecadotril plus ORS

About this trial

This is an interventional treatment trial for Diarrhea, Infantile

Eligibility Criteria

3 Months - 60 Months (Child)All SexesDoes not accept healthy volunteers

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)

Exclusion Criteria:

Known allergy to Racecadotril or any of its ingredients
Subjects suffering from renal or hepatic impairment
Subjects with fever > 39 degrees Celsius
Subjects with bloody and/or purulent stools
Subjects suffering from antibiotic (e.g. amoxicillin)-associated diarrhea, chronic diarrhea or iatrogenic diarrhea
Subjects with alternating bouts of diarrhea and constipation
Diarrhea due to exacerbation of chronic gastrointestinal diseases such as irritable bowel syndrome, irritable bowel disease or pancreatic exocrine insufficiency
Cystic fibrosis or coeliac disease
Subjects suffering from prolonged or uncontrolled vomiting
Subjects with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency
Subjects having received antibiotic treatment at any time within 2 weeks prior to inclusion into the study
Subjects having received antidiarrheal drugs 48 hours prior to inclusion into the study
Subjects with severe dehydration requiring intravenous fluid, electrolyte replacement or hospitalization treatment
Subject with a history of angioedema or who had reported angioedema with angiotensin converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril)
Subjects with combined diseases or medical situations that would prevent to be enrolled into the study, depending on the judgment of the investigator
Intake of experimental drug within 30 days prior to study start
Subjects with contraindications to ORS or susceptible to the warnings of ORS

Sites / Locations

Linkou Chang Gung Memorial Hospital
Mackay Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Racecadotril plus standard treatment oral rehydration solution

Arm Description

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)

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Number of recovered subjects

Global Physician Assessment at the end of treatment

scores 1-6

Full Information

NCT ID

NCT03473561

First Posted

March 12, 2018

Last Updated

December 14, 2021

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT03473561

Brief Title

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

Official Title

Efficacy and Safety of Racecadotril in the Treatment of Taiwanese Children Aged 3 to 60 Months Suffering From Acute Diarrhea: A Prospective, Open-label, Multicenter, Single-arm Study.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

August 25, 2018 (Actual)

Primary Completion Date

January 8, 2020 (Actual)

Study Completion Date

January 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a prospective, open-label, multicenter, single-arm study evaluating the efficacy and safety of Racecadotril the treatment of children aged 3 to 60 months suffering from acute diarrhea

Detailed Description

Subjects presenting with acute diarrhea will be evaluated for eligibility. If eligible, demographics, number of stools during the last 12 hours will be assessed as baseline values. On Day 1, the subject will start with study treatment. Subjects will be treated with Racecadotril three times daily according to the body weight dose requirement on an out-patient basis for maximum 5 days in addition to ORS. ORS will be prescribed by the investigator. The parent(s)/caregiver(s)/legal representative(s) will be instructed to stop treatment when the patient recovered. Recovery is defined by the evacuation of the first of two consecutive normal stools or no stool within 12 hours. In the evening of each day, the parent(s)/caregiver(s)/legal representative(s) will fill in their diaries, documenting date and time of each individual stool, the stool consistency of each stool, ORS amount and the study drug intake. AEs are to be reported on an ongoing basis. The last dose of study drug intake will be the morning dose of day 6, if not recovered earlier. The parent(s)/caregiver(s)/legal representative(s) will visit the site for the end of study visit of the child. Data on vital signs, AEs, physical examination and concomitant medication will be collected. The parent(s)/caregiver(s)/legal representative(s) will return the diaries and unused medication. A phone call contact will be performed 5-7 days after the end of the treatment period or recovery for the safety follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhea, Infantile

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Racecadotril plus standard treatment oral rehydration solution

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Racecadotril plus ORS

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

5 days

Secondary Outcome Measure Information:

Title

Number of recovered subjects

Description

Number of recovered subjects

Time Frame

5 days

Title

Global Physician Assessment at the end of treatment

Description

scores 1-6

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

60 Months

Accepts Healthy Volunteers

Eligibility Criteria

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) Exclusion Criteria: Known allergy to Racecadotril or any of its ingredients Subjects suffering from renal or hepatic impairment Subjects with fever > 39 degrees Celsius Subjects with bloody and/or purulent stools Subjects suffering from antibiotic (e.g. amoxicillin)-associated diarrhea, chronic diarrhea or iatrogenic diarrhea Subjects with alternating bouts of diarrhea and constipation Diarrhea due to exacerbation of chronic gastrointestinal diseases such as irritable bowel syndrome, irritable bowel disease or pancreatic exocrine insufficiency Cystic fibrosis or coeliac disease Subjects suffering from prolonged or uncontrolled vomiting Subjects with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency Subjects having received antibiotic treatment at any time within 2 weeks prior to inclusion into the study Subjects having received antidiarrheal drugs 48 hours prior to inclusion into the study Subjects with severe dehydration requiring intravenous fluid, electrolyte replacement or hospitalization treatment Subject with a history of angioedema or who had reported angioedema with angiotensin converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril) Subjects with combined diseases or medical situations that would prevent to be enrolled into the study, depending on the judgment of the investigator Intake of experimental drug within 30 days prior to study start Subjects with contraindications to ORS or susceptible to the warnings of ORS

Facility Information:

Facility Name

Linkou Chang Gung Memorial Hospital

City

Taipei

Country

Taiwan

Facility Name

Mackay Memorial Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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