Viewing Study NCT01393548



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Last Modification Date: 2024-10-26 @ 10:38 AM
Study NCT ID: NCT01393548
Status: COMPLETED
Last Update Posted: 2017-01-13
First Post: 2010-10-27

Brief Title: Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
Sponsor: Ache Laboratorios Farmaceuticos SA
Organization: Ache Laboratorios Farmaceuticos SA

Study Overview

Official Title: 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
Status Verified Date: 2017-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None