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

NCT03463512 | Completed Phase 3 Results

• 1 other identifier: RACE3003
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Racecadotril plus standard treatment oral rehydration solution

EXPERIMENTAL

Drug: Racecadotril plus ORS

ORS (standard treatment)

ACTIVE COMPARATOR

Drug: ORS

Interventions

Racecadotril plus ORS DRUG

Racecadotril plus ORS

Racecadotril plus standard treatment oral rehydration solution

ORS DRUG

ORS

ORS (standard treatment)

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

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

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Diarrhea

Interventions

racecadotril; ORALIT

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Suntje Sander
• Organization: Abbott

suntje.sander@abbott.com

+495116750

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 13, 2018
• Study Start: March 29, 2018
• Primary Completion: September 10, 2018
• Study Completion: September 10, 2018
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)