DOUBLE BLIND STUDY, RANDOMIZED, TO EVALUATE THE EFFICACY AND CLINICAL SAFETY OF FOUR DOSE OF ORDERSTRAND ORAL IN ASSOCIATION WITH 10 MG. DEXECADOTRIL IN CHILD MALE FROM 3 TO 36 MONTHS AGE, WITH ACUTE DIARRHEA OF ALLEGED INFECTIOUS ORIGI

Not Applicable

• Conditions: -R194 Change in bowel habit; Change in bowel habit; R194

• Registration Number: PER-033-07
• Lead Sponsor: CONSULTORES ASOCIADOS PARA EL DESARROLLO DE LA SALUD. DS-CONSULT S.A.C.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Male patients from 3 months of age to 36 months of age, suffering from acute diarrhea, of presumed infectious origin.
2. Written informed consent granted by the parent or legal guardian.

Exclusion Criteria

1. Previous episode of diarrhea within the last 2 weeks.
2. Presence of blood in the stool.
3. Patients who have received treatment with antibiotics at a therapeutic dose for one day, within the previous 48 hours. Use of acetylsalicylic acid, antidiarrheal or antiemetic, at any dose in the last 12 hours.
4. Severe malnutrition.
5. Any other disease or condition that requires antibiotic therapy at the time of inclusion.
6. Severe dehydration requiring intravenous rehydration.
7. Known hypersensitivity to Racecadotril or Ondansetron.
8. Previous diagnosis of lactose intolerance.
9. Concomitant disease that could interact with the study.
10. Patients who participate in another study or who have participated in a study during the preceding month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified