NCT01533220

Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal

A Randomized, Double-blind, Prospective, Multicentric, Superior Efficacy and Safety of Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal Due to Colds or Other Upper Respiratory Allergies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The common cold is a major cause of nasal obstruction and reaches children and adults two or more times a year. At the moment, there is no cure for the common cold, and therefore the reduction of symptoms is the focus of the treatment. The study has parallel distribution design, with two equal groups, in which one group will be treated by a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.

Detailed description

STUDY DESIGN * randomized,double blind, prospective, multicentric, parallel group, intent to treat trial * Experiment duration: 3 days * 2 visits (days 0 and 2) * Evaluation of symptoms reduction * Adverse events evaluation

Conditions

• Flu
• Cold
• Allergic Disorder of Respiratory System

Interventions

Type	Name	Description
DRUG	naphazoline hydrocloride	02 drops into each nostril, 04 times a day for 03 days
DRUG	Naphazoline hydrocloride + Pheniramine Maleate + Panthenol	02 drops into each nostril each 12 hours for 03 days

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-08-31
• Completion: 2014-04-30
• First posted: 2012-02-15
• Last updated: 2019-01-25