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

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

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

Study Overview

• Status: Completed
• Conditions: Diarrhea
• Intervention / Treatment: Drug: Racecadotril plus ORS; Drug: ORS

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation
    • Saint Petersburg State Budgetary Healthcare Institution "Municipal Outpatient Children Unit #45"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Racecadotril plus standard treatment oral rehydration solution	Drug: Racecadotril plus ORS; Racecadotril plus ORS
Active Comparator: ORS (standard treatment)	Drug: ORS; ORS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 days
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	5 days

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Actual): September 10, 2018
• Study Completion (Actual): September 10, 2018

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Protease Inhibitors; Antidiarrheals; Racecadotril
• Other Study ID Numbers: RACE3003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No