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

Completed

• 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

• Study Start: 1999-07-05
• Last Update Posted: 2023-09-04

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