Efficacy and Safety of Pediatric Drugs in Nasal Congestion

NCT02601235 | Completed Phase 3

• 1 other identifier: NMDEMS0214NA-III
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of the Naridrin in improving nasal congestion.

Conditions

Nasal Congestion

Keywords

nasal congestion

Outcome Measures

Primary Outcomes (1)

• Relief of Nasal Congestion

  Relief of nasal congestion will be measured on a scale of 0 to 3 (0 = without congestion and 3 total congestion)

  2 days

Secondary Outcomes (1)

• Adverse Events

  2 days

Study Arms (2)

Naridrin

EXPERIMENTAL

Naridrin: 2 drops in each nostril once daily as prescription

Drug: Naridrin

0.05 % Oxymetazoline Hydrochloride

ACTIVE COMPARATOR

2 pumps in each nostril every 12 hours

Drug: Afrin

Interventions

Naridrin DRUG

Naridrin® : 2 drops in each nostril once daily as prescription

Also known as: Naphazoline Hydrochloride, Mepyramine Maleate, Dexpanthenol

Naridrin

Afrin DRUG

2 pumps in each nostril every 12 hours.

Also known as: oxymetazoline hydrochloride

0.05 % Oxymetazoline Hydrochloride

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants aged 10-17 years old with clinical symptoms of inflammatory of allergic nasal congestion in at least one nostril due to rhinitis or rhinopharyngitis (cold or flu);
• Signed Consent;
• Participants whose mother, father and / or legal guardian is in accordance with all study purposes and procedures;
• Participants with clinical symptoms of nasal congestion in at least one nostril diagnosed through the Glatzel mirror;
• Participants with minimal score of 2 points in the 0 to 3 scale (Moderate obstruction).

You may not qualify if:

• Participation in clinical trial in the year prior to this study;
• Total obstruction of one of the nostrils by other etiologies that are not inflammatory or allergic;
• Infectious bacterial-disease (clinically diagnosed);
• Participants treated with antibiotic or possible antibiotic use due to another medical condition;
• Use of intranasal corticosteroids (7 days prior to the study) or systemic (15 days prior to the study), regarding the plasma half-life of the drug;
• Use of decongestants or antihistamine (intranasal or systemic) in the 03 days prior to the study;
• Use of inhaled drugs (except nasal moisturizers such as saline solution) or treatment with immunosuppressants in the week before the study;
• Participants with septum deviation grade II and III, nasal polyps, severe turbinate hypertrophy, adenoid hypertrophy, or other determining factors for nasal obstruction;
• History of hyperthyroidism or hypertension;
• History of hypersensitivity to the components of the study drugs;
• History of transphenoidal hypophysectomy or oronasal surgery with exposure of the dura-mater;
• Exclusive mouth-breathers patients;
• Participants in chronic drug treatment for allergies (eg vaccines for allergy, cromolyn);
• History of alcohol and / or drug abuse 3 months prior to the study;
• Smokers

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Location

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Naphazoline; Pyrilamine; dexpanthenol; Oxymetazoline

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 10, 2015
• Study Start: January 16, 2018
• Primary Completion: August 3, 2018
• Study Completion: April 3, 2019
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

BR (1)