Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 31, 2011

Primary Completion Date

April 30, 2012

Conditions
InflammationCoughRhinitis
Interventions
DRUG

diphenhydramine + dropropizine + pseudoephedrine

"Group 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).~Posology: The medicine treat will be as follows:~\- Notuss® syrup Age: 2-5 years / Dosage: 5,0 mL Age: 6-12 years / Dosage: 10,0 ml"

DRUG

Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir).

"Dropropizine:~Age: 2 - 3 years / Dosage: 5,0 ml Age: 4 - 12 years / Dosage: 10,0 ml~Pseudoephedrine hydrochloride + brompheniramine maleate:~Age: 2 - 3 years / Dosage: 2,5 ml Age: 4 - 6 years / Dosage: 5,0 ml Age: 7 - 9 years / Dosage: 7,5 ml Age: 10 - 12 years / Dosage: 10,0 ml"

All Listed Sponsors
lead

Ache Laboratorios Farmaceuticos S.A.

INDUSTRY