Ignite Creation Date:
2024-05-05 @ 10:51 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01199497
Status:
WITHDRAWN
Last Update Posted:
2017-07-13
First Post:
2010-09-09
Brief Title:
Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine Pseudoephedrine Dropropizine in the Control of Cough and the Relief of Nasal Symptoms Suffering From Non-productive Cough and Acute 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 Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine Pseudoephedrine Dropropizine in the Control of Cough and the Relief of Nasal Symptoms in Subjects Above 12 Years of Age Suffering From Non-productive Cough and Acute Rhinitis
Status:
WITHDRAWN
Status Verified Date:
2017-07
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 double-blind randomized enroll 208 subjects above 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