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

NCT ID: NCT03463512

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-29
• Study Completion Date: 2018-09-10

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

Conditions

Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Racecadotril plus standard treatment oral rehydration solution

Group Type: EXPERIMENTAL

Racecadotril plus ORS

Intervention Type: DRUG

Racecadotril plus ORS

ORS (standard treatment)

Group Type: ACTIVE_COMPARATOR

ORS

Intervention Type: DRUG

ORS

Interventions

Racecadotril plus ORS

Racecadotril plus ORS

Intervention Type: DRUG

ORS

ORS

Intervention Type: DRUG

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Saint Petersburg, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RACE3003

Identifier Type: -

Identifier Source: org_study_id