Efficacy and Safety of Pediatric Drugs in Nasal Congestion

NCT ID: NCT02601235

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-16
• Study Completion Date: 2019-04-03

Brief Summary

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

Detailed Description

Open label, randomized, multicenter clinical study. Maximal experiment duration: 2 days; 2 visits. Safety and efficacy evaluation

Conditions

Nasal Congestion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Naridrin

Naridrin: 2 drops in each nostril once daily as prescription

Group Type: EXPERIMENTAL

Naridrin

Intervention Type: DRUG

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

0.05 % Oxymetazoline Hydrochloride

2 pumps in each nostril every 12 hours

Group Type: ACTIVE_COMPARATOR

Afrin

Intervention Type: DRUG

2 pumps in each nostril every 12 hours.

Interventions

Naridrin

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

Intervention Type: DRUG

Afrin

2 pumps in each nostril every 12 hours.

Intervention Type: DRUG

Other Intervention Names

Naphazoline Hydrochloride; Mepyramine Maleate; Dexpanthenol; oxymetazoline hydrochloride

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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
• Pregnancy or risk of pregnancy and lactating patients;
• PAny clinical, laboratory that, in the judgment of the investigator, may interfere with the safety of research participants.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Countries

Brazil

Other Identifiers

NMDEMS0214NA-III

Identifier Type: -

Identifier Source: org_study_id