Ignite Creation Date:
2024-05-05 @ 10:45 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01177852
Status:
WITHDRAWN
Last Update Posted:
2016-10-19
First Post:
2010-08-06
Brief Title:
Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years OldSuffering From Cough and Acute Rhinitis
Sponsor:
Ache Laboratorios Farmaceuticos SA
Organization:
Ache Laboratorios Farmaceuticos SA
Study Overview
Official Title:
Multicenter Clinical Trial Phase III Controlled Open Parallel Group Randomized Comparing the Fixed Dose Combination of Diphenhydramine Dropropizine Pseudoephedrine and the Combined Use of Dropropizine and Fixed Dose Combination of Pseudoephedrine Hydrochloride Brompheniramine Maleate Used Orally for Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2 to 12 Years Old Suffering From Non-productive Cough and Acute Rhinitis
Status:
WITHDRAWN
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:
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 daytimenighttime with duration for at least 3 and no more than 5 consecutive days without systemictopic use of medication during this period followed by nasal congestion with or without associate other nasal symptoms sneezing runny nose nasal itching andor mouth breathing 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