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

Abbott1 site in 1 country124 target enrollmentMarch 29, 2018

ConditionsDiarrhea

InterventionsRacecadotril plus ORS ORS

DrugsRacecadotril plus ORS ORS

Overview

Phase: Phase 3
Intervention: Racecadotril plus ORS
Conditions: Diarrhea
Sponsor: Abbott
Enrollment: 124
Locations: 1
Primary Endpoint: 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)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 29, 2018

End Date

September 10, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott

Responsible Party

Sponsor

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

Arms & Interventions

Racecadotril plus standard treatment oral rehydration solution

Intervention: Racecadotril plus ORS

ORS (standard treatment)

Intervention: ORS

Outcomes

Primary Outcomes

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)

Time Frame: 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 Outcomes

Number of Recovered Subjects Per Treatment Group.(5 days)
Number of Recovered Subjects as Defined by Global Physician Assessment of Success at the End of Treatment(5 days)