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

Study Overview
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Brief Summary
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Multicenter, open-label, controlled, randomized clinical study to evaluate the efficacy and safety of Racecadotril in infants, children and adolescents with acute diarrhea

Official Title
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Multicenter, Open-label, Controlled, Randomized Clinical Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea

Conditions
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Diarrhea

Intervention / Treatment
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* Drug: Racecadotril plus ORS
* Drug: ORS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Racecadotril plus standard treatment oral rehydration solution<br> | Drug: Racecadotril plus ORS<br>* Racecadotril plus ORS<br>|
| Active Comparator: ORS (standard treatment)<br> | Drug: ORS<br>* ORS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Recovered Subjects Per Treatment Group. | Number of recovered subjects per treatment group. Recovery is defined as the evacuation of the first of two consecutive normal stools or no stool within 12 h within treatment period | 5 days | 
| Number of Recovered Subjects as Defined by Global Physician Assessment of Success at the End of Treatment | Globabl physician assessment used 6 scores with a score of 1 or 2 being regarded as treatment success | 5 days |