NCT01259674

Evaluation of the Efficacy and Tolerability of ABO/MEG-B-09 in Children With Acute Cough

Randomized, Single-center, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Tolerability of ABO/MEG-B-09 in Pediatric Cough

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Aboca Spa Societa' Agricola · Industry
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

The present clinical trial will examine the use of ABO/MEG-B-09 syrup in children with acute cough as compared to a placebo syrup.

Detailed description

Subjects will be asked to take 4 doses of 5 ml containing a mixture of honey and other natural ingredients or a placebo syrup everyday, during 8 days. The following outcomes will be noted down in a diary: occurence and severity of diurnal and nocturnal cough events (cough score) and symptoms, impediment of normal life activities (school, sleeping), the number of medical visits and type of medication needed if any.

Conditions

• Cough

Interventions

Type	Name	Description
DEVICE	AboMeg-B-09	Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period
OTHER	Placebo	Placebo syrup: 5ml to be taken 4 times a day during the entire study period

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-12-14
• Last updated: 2014-12-02

Locations

1 site across 1 country: Italy