Ignite Creation Date:
2024-05-05 @ 11:41 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01393561
Status:
COMPLETED
Last Update Posted:
2016-10-31
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 Clinical Trial Phase III Randomized Double-blind Placebo Controlled Comparative for Evaluate the Efficacy and Safety of Fixed Dose Combination of Brompheniramine Maleate Phenylephrine Chlorhydrate for the Treatment of Nasal Congestion and Runny Nose Present in Acute Crisis of Viral Rhinitis Common Cold and Allergic Reactions in Patients Over 12 Years Old
Status:
COMPLETED
Status Verified Date:
2016-10
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 superiority controlled by active medicine double-blind randomized enroll 166 children over 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:
None
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