Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea

NCT03473561 | Completed Phase 3 Results

• 1 other identifier: RACE3002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, open-label, multicenter, single-arm study evaluating the efficacy and safety of Racecadotril the treatment of children aged 3 to 60 months suffering from acute diarrhea

Conditions

Diarrhea, Infantile

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

  5 days

Secondary Outcomes (2)

• Number of Recovered Subjects

  5 days

• Global Physician Assessment at the End of Treatment

  5 days

Study Arms (1)

Racecadotril plus standard treatment oral rehydration solution

EXPERIMENTAL

Racecadotril Infants Granules for Oral Suspension 10 mg (in addition to standard treatment i.e. oral rehydration solution) Racecadotril Children Granules for Oral Suspension 30 mg (in addition to standard treatment i.e. oral rehydration solution)

Drug: Racecadotril plus ORS

Interventions

Racecadotril plus ORS DRUG

1.5 mg/kg of Racecadotril will be administered, 3 times daily, via the oral route (in addition to standard treatment i.e. oral rehydration solution). In infants less than 9 kg: one 10 mg sachet 3 times daily. In infants from 9 kg to \< 13 kg: two 10 mg sachets 3 times daily. In children from 13 kg to 27 kg: one 30 mg sachet 3 times daily. In children of more than 27 kg: two 30 mg sachets 3 times daily.

Racecadotril plus standard treatment oral rehydration solution

Eligibility Criteria

• Age: 3 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Signed informed consent from one of the parent(s)/legal representative(s)
• Subjects, both genders, aged 3 to 60 months
• Subjects with acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than 3 days)

You may not qualify if:

• Known allergy to Racecadotril or any of its ingredients
• Subjects suffering from renal or hepatic impairment
• Subjects with fever \> 39 degrees Celsius
• Subjects with bloody and/or purulent stools
• Subjects suffering from antibiotic (e.g. amoxicillin)-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, irritable 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 intolerance, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency
• Subjects with severe dehydration requiring intravenous fluid, electrolyte replacement or hospitalization treatment
• Subject with a history of angioedema or who had 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 into the study, depending on the judgment of the investigator
• Intake of experimental drug within 30 days prior to study start
• Subjects with contraindications to ORS or susceptible to the warnings of ORS

Sponsors & Collaborators

• Abbott: lead

Study Sites (2)

Linkou Chang Gung Memorial Hospital

Taipei, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Diarrhea, Infantile

Interventions

racecadotril; ORALIT

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Suntje Sander, PhD
• Organization: Abbott Laboratories

suntje.sander@abbott.com

0049 - 511 - 6750 3254

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 22, 2018
• Study Start: August 25, 2018
• Primary Completion: January 8, 2020
• Study Completion: January 8, 2020
• Last Updated: November 24, 2023
• Results First Posted: November 24, 2023

Record last verified: 2023-02

Locations

TW (2)