drugset
drugset / Trial / NCT01177852

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

NCT01177852 ↗

Phase 3 Withdrawn Ache Laboratorios Farmaceuticos S.A.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-10
Primary completion
2012-04
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Comparator Brompheniramine Small molecule 2.5 ml Oral
Comparator Brompheniramine Small molecule 5 ml Oral
Comparator Brompheniramine Small molecule 7.5 ml Oral
Comparator Brompheniramine Small molecule 10 ml Oral
Subject Diphenhydramine Unknown 5 ml Oral
Subject Diphenhydramine Unknown 10 ml Oral
Background Pseudoephedrine Small molecule 2.5 ml Oral
Background Pseudoephedrine Small molecule 5 ml Oral
Background Pseudoephedrine Small molecule 7.5 ml Oral
Background Pseudoephedrine Small molecule 10 ml Oral
Background dropropizine Unknown 5 ml Oral
Background dropropizine Unknown 10 ml Oral

Indications

rhinitis