NCT02656888

Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children

Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical efficacy of the drug associations in the treatment of common cold symptoms.

Detailed description

Double-blind,randomized, multicenter; Maximal experiment duration: 7 days; 03 visits; Safety and efficacy evaluation.

Conditions

• Common Cold

Interventions

Type	Name	Description
DRUG	Irlanda-1-Association	For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route.
DRUG	Placebo	For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route.

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-06-01
• Completion: 2020-09-01
• First posted: 2016-01-15
• Last updated: 2019-10-16

Locations

1 site across 1 country: Brazil