CLINICAL RESEARCH PROJECT ON A MULTI-CENTRE RANDOMIZED DOUBLE-BLIND PLACEBO CONTROLLED IN PARALLEL GROUPS STUDY TO EVALUATE THE EFFECTIVENESS SAFETY AND TOLERABILITY OF TIORFAN 1.5 MG / KG BODY WEIGHT ADMINISTERED 3 TIMES PER DAY ORALLY JOINTLY WITH ORAL REHYDRATION TREATMENT VERSUS PLACEBO IN CONJUNCTION WITH ORAL TREATMENT OF REHYDRATION IN THE TREATMENT OF ACUTE DIARRHEA IN CHILDREN.

Not Applicable

• Conditions: -K591 Functional diarrhoea; Functional diarrhoea; K591

• Registration Number: PER-031-99
• Lead Sponsor: SMITHKLINE BEECHAM INTERAMERICAN,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1999-07-05
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1 Male patients, from 6 months to 3 years of age
2 Patients with a clinical history of acute watery diarrhea of less than 3 days.
3 Patients with three or more watery stools in the last 24 hours.
4 Symptoms and clinical signs of certain dehydration.
5 Normal nutritional status or mild or moderate malnutrition (weight / height ratio ≥70%).
6 Written or oral Informed Consent (with witnesses) must be obtained from the patient´s parents or legal guardians.

Exclusion Criteria

1 The patient has previously shown hypersensitivity to enkephalinase inhibitors and / or mu receptor agonists.
2 Female patients.
3 Clinical signs or symptoms of absence of dehydration or severe dehydration.
4 Severe malnutrition (weight / height ratio <70% or nutritional edema).
5 The patient suffers from chronic or iatrogenic diarrhea or dysenteric syndrome characterized by loss of macroscopic blood in fecal matter
6 The patient has received a research drug within 30 days or 5 half lives (whichever is longer) of the screening period or is scheduled to receive the drug during the study period.
7 The patient has a concomitant infection or any other major disease that could compromise the diagnosis and evaluation of the response to the study medication.
8 The patient has a known history of renal dysfunction (plasma creatinine 1.5 times lower than normal for age) or hepatic dysfunction (liver enzymes 1.5 times higher than the upper limit of the range for age).
9 The patient unable to participate in this study.
10 The patient has already been previously included in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The duration of diarrhea will be recorded before the inclusion of the patient in the study and the number of stools that occurred during the preceding 24 hours.<br>The depositions occurred will be measured and recorded in gr.<br><br>Measure:Evaluation of Diarrhea<br>Timepoints:- During the four hours of the observation period (Hour -4 to Hour 0)<br>- From the moment of the randoraización and the beginning of the treatment with the medication of the study (Hour 0) and to 4, 8, 16, 24, 48 hs and every 24 subsequent hours until the resolution of the diarrhea or until a maximum of 7 days.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:The nutritional status of the children included in the study will be based on the proportion of weight (kg) by height (cm) expressed as a percentage of the average weight by height expected using the NCHS reference standards.<br>(National Center for Health Statistics)<br>Measure:Nutritional Status Evaluation<br>Timepoints:Duration of the study<br>;<br>Outcome name:Urine excretion will be measured from the moment the patient enters the study. The total volume of urine excreted, even if it is 1 ml, will be recorded.<br>Measure:Evaluation of excreted urine<br>Timepoints:Urine excretion will be measured from the moment the patient enters the study.<br>It will be recorded at the end of the observation period of 4 hours and at 4, 8, 16, 24 hours and every 24 hours after the administration of the study drug and until the resolution of the diarrhea.<br>