NCT01393548

Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis

Multicenter, Phase III, Randomized, Open, Parallel, Comparative to Evaluate the Efficacy and Safety of the Treatment of Nasal Congestion and Runny Nose Present in Acute Crisis of Viral Rhinitis and Allergic Reactions, in Pediatric Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 879 (actual)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter clinical trial, phase III, non-inferiority, controlled by active medicine, open, randomized, enroll 538 children, 2 to 12 years old, with acute inflammation upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours and a maximum of 48 hours prior to inclusion. The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.

Detailed description

This study evaluate the efficacy and safety of experimental drug The study was designed to evaluate the efficacy and safety of fixed combinations Decongex® Plus Syrup and Decongex® Plus Oral Solution (consisting of brompheniramine maleate and phenylephrine hydrochloride) compared to Resfenol® Oral Solution (paracetamol, maleate chlorpheniramine and phenylephrine hydrochloride) in the treatment of nasal congestion and rhinorrhea present in acute attacks of viral rhinitis (common cold) and allergic. This study population will consist in participants of both sexes, aged between 6 to 11 years old with acute inflammatory condition of the upper airways, defined as nasal congestion and runny nose, with no less than 24 (twenty four) hours and a maximum of 48 (forty-eight) hours prior to inclusion.

Conditions

• Nasal Congestion and Inflammations
• Rhinitis

Interventions

Type	Name	Description
DRUG	brompheniramine + phenylephrine	Oral solution: brompheniramine (2mg/mL) and phenylephrine (2,5 mg/mL), t.i.d., according weight of patient. OR Syrup: brompheniramine (2mg/5mL) and phenylephrine(5 mg/5mL), t.i.d., according weight of patient.
DRUG	Brompheniramine + pseudoephedrine	Elixir: Brompheniramine (0,2mg/mL) and pseudoephedrine (3,0 mg/mL), t.i.d., according weight of patient

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2011-07-13
• Last updated: 2017-01-13

Locations

1 site across 1 country: Brazil