Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-30 @ 5:07 PM
Study NCT ID:
NCT01448057
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2011-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
Sponsor:
Novartis
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Investigator-Blind Study to Compare Three Days of Treatment With Paracetamol (500 mg) / Dimethindene Maleate (1 mg) / Phenylephrine Hydrochloride (10 mg) Tablets Versus Paracetamol 500 mg Alone in the Treatment of Nasal Congestion and Other Symptoms Due to Cold and Flu
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:
The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: