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Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With 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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03463512
Recruitment Status : Completed
First Posted : March 13, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open-label, Controlled, Randomized Clinical Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea
Actual Study Start Date : March 29, 2018
Actual Primary Completion Date : September 10, 2018
Actual Study Completion Date : September 10, 2018

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

Active Comparator: ORS (standard treatment) Drug: ORS
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 per treatment group [ Time Frame: 5 days ]
    Number of recovered subjects per treatment group

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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 ClinicalTrials.gov identifier (NCT number): NCT03463512


Locations
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Russian Federation
Saint Petersburg State Budgetary Healthcare Institution "Municipal Outpatient Children Unit #45"
Saint Petersburg, Russian Federation
Sponsors and Collaborators
Abbott

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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT03463512     History of Changes
Other Study ID Numbers: RACE3003
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Racecadotril
Thiorphan
Antidiarrheals
Gastrointestinal Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action