Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03473561
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 25, 2019
Information provided by (Responsible Party):

Brief Summary:
Efficacy and Safety of Racecadotril in the treatment of children aged 3 to 60 months suffering from acute diarrhea: An open-label study

Condition or disease Intervention/treatment Phase
Diarrhea, Infantile Drug: Racecadotril plus ORS Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Racecadotril in the Treatment of Children Aged 3 to 60 Months Suffering From Acute Diarrhea: An Open-label Study
Actual Study Start Date : August 25, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Racecadotril plus standard treatment oral rehydration solution Drug: Racecadotril plus ORS
Racecadotril plus ORS

Primary Outcome Measures :
  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 [ 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

Secondary Outcome Measures :
  1. Number of recovered subjects [ Time Frame: 5 days ]
    Number of recovered subjects

  2. Global Physician Assessment at the end of treatment [ Time Frame: 5 days ]
    scores 1-6

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   3 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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 having received antibiotic treatment at any time within 2 weeks prior to inclusion into the study
  • Subjects having received antidiarrheal drugs 48 hours prior to inclusion into the study
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03473561

Layout table for location contacts
Contact: Suntje Sander, PhD +49 511 6750 ext 3254

Layout table for location information
Chang Gung Children's Hospital Recruiting
Taipei, Taiwan
Contact: Cheng-Hsun Chiu, Dr         
Sponsors and Collaborators

Layout table for additonal information
Responsible Party: Abbott Identifier: NCT03473561     History of Changes
Other Study ID Numbers: RACE3002
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Diarrhea, Infantile
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action