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Oral Administration of Actitan-F in Paediatric Diarrhoea

NCT05904938 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2024-05-07

No results posted yet for this study

Summary

The goal of the study is to investigate the efficacy and safety of Lenodiar Pediatric (product under investigation) for the treatment of Chronic Diarrhoea (functional or post-infective diarrhoea) in children aged 1-5 years old, through a randomized, double blind, placebo-controlled clinical investigation

Conditions

  • Chronic Diarrhoea of Infants and/or Young Children

Interventions

DEVICE

Lenodiar Pediatric

Medical Device made of natural substance

OTHER

Placebo

Product appearance similar to verum without clinical efficacy

Sponsors & Collaborators

  • IQVIA RDS Inc.

    collaborator INDUSTRY

  • IQVIA Solutions

    collaborator UNKNOWN

  • Aboca Spa Societa' Agricola

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-10
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05904938 on ClinicalTrials.gov