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

Primary Purpose

Diarrhea

Status

Completed

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

Racecadotril plus ORS

ORS

About this trial

This is an interventional treatment trial for Diarrhea

Eligibility Criteria

3 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent from one of the parent(s)/caregiver(s) or subject informed assent
Children and adolescents, both genders, age from 3 months to < 18 years of age
Confirmed diagnosis of acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than three days)
Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection, an intrauterine device, or an oral contraceptive taken within the past three months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide

Exclusion Criteria:

Known allergy to Racecadotril or any of its ingredients
Subjects suffering from renal or hepatic impairment
Subjects who need treatment for diarrhea other than ORS alone
Subjects with fever > 39 degrees Celsius
Subjects with bloody and/or purulent stools
Subjects suffering from antibiotic-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, inflammatory 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 or galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency or primary or secondary lactase insufficiency
Subjects having received antibiotic treatment at any time within 30 days prior to inclusion into the study
Subjects having received antidiarrheal drugs 48 hours prior to inclusion into the study
Subjects with severe dehydration required for intravenous/parenteral rehydration
Subjects who have 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 depending in the judgment of the investigator
Intake of experimental drug within 30 days prior to study start
Subjects with contraindications to ORS or for whom warnings/precautions of ORS apply
Adolescents (≥ 60 kg) not able to swallow capsules
Pregnancy and lactation

Sites / Locations

Saint Petersburg State Budgetary Healthcare Institution "Municipal Outpatient Children Unit #45"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Racecadotril plus standard treatment oral rehydration solution

ORS (standard treatment)

Arm Description

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. Log-rank test was performed with a p-value < 0.0001

Secondary Outcome Measures

Number of Recovered Subjects Per Treatment Group.

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

Number of Recovered Subjects as Defined by Global Physician Assessment of Success at the End of Treatment

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

Full Information

NCT ID

NCT03463512

First Posted

March 5, 2018

Last Updated

October 22, 2019

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT03463512

Brief Title

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

Official Title

Multicenter, Open-label, Controlled, Randomized Clinical Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

March 29, 2018 (Actual)

Primary Completion Date

September 10, 2018 (Actual)

Study Completion Date

September 10, 2018 (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

Multicenter, open-label, controlled, randomized clinical study to evaluate the efficacy and safety of Racecadotril in infants, children and adolescents with acute diarrhea

6. Conditions and Keywords

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

Diarrhea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Racecadotril plus standard treatment oral rehydration solution

Arm Type

Experimental

Arm Title

ORS (standard treatment)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Racecadotril plus ORS

Intervention Description

Racecadotril plus ORS

Intervention Type

Drug

Intervention Name(s)

ORS

Intervention Description

ORS

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. Log-rank test was performed with a p-value < 0.0001

Time Frame

5 days

Secondary Outcome Measure Information:

Title

Number of Recovered Subjects Per Treatment Group.

Description

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

Time Frame

5 days

Title

Number of Recovered Subjects as Defined by Global Physician Assessment of Success at the End of Treatment

Description

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

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent from one of the parent(s)/caregiver(s) or subject informed assent Children and adolescents, both genders, age from 3 months to < 18 years of age Confirmed diagnosis of acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than three days) Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection, an intrauterine device, or an oral contraceptive taken within the past three months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide Exclusion Criteria: Known allergy to Racecadotril or any of its ingredients Subjects suffering from renal or hepatic impairment Subjects who need treatment for diarrhea other than ORS alone Subjects with fever > 39 degrees Celsius Subjects with bloody and/or purulent stools Subjects suffering from antibiotic-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, inflammatory 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 or galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency or primary or secondary lactase insufficiency Subjects having received antibiotic treatment at any time within 30 days prior to inclusion into the study Subjects having received antidiarrheal drugs 48 hours prior to inclusion into the study Subjects with severe dehydration required for intravenous/parenteral rehydration Subjects who have 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 depending in the judgment of the investigator Intake of experimental drug within 30 days prior to study start Subjects with contraindications to ORS or for whom warnings/precautions of ORS apply Adolescents (≥ 60 kg) not able to swallow capsules Pregnancy and lactation

Facility Information:

Facility Name

Saint Petersburg State Budgetary Healthcare Institution "Municipal Outpatient Children Unit #45"

City

Saint Petersburg

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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