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

• Status: Withdrawn
• Trial end date: 1969-12-31

Summary

Multicenter clinical trial, phase III, controlled by active medicine, open, randomized, enroll 962 children, 2 to 12 years old, that suffer acute inflammation upper airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no more than 5 consecutive days (without systemic/topic use of medication during this period) followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.

• Phase: Phase 3

Details

• Lead Sponsor: Ache Laboratorios Farmaceuticos S.A.
• Treatments: Brompheniramine; Brompheniramine, pseudoephedrine drug combination; Diphenhydramine; Dipropizine; Ephedrine; Maleic acid; Promethazine; Pseudoephedrine