Efficacy and Safety of Pediatric Drugs in Nasal Congestion

Nasal Congestion Clinical Trial

Official title:

Clinical Evaluation of Safety and Efficacy of Pediatric Naridrin in Comparison to Afrin on the Improval of Nasal Congestion.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601235
• Other study ID #: NMDEMS0214NA-III
• Status: Completed
• Phase: Phase 3
• Start date: January 16, 2018
• Est. completion date: April 3, 2019

Study information

• Verified date: October 2019
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: April 3, 2019
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Congestion

Intervention

Drug:
• Naridrin
Naridrin® : 2 drops in each nostril once daily as prescription
• Afrin
2 pumps in each nostril every 12 hours.

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina do ABC	Santo André	SP

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse Events	Safety of the drug will be assessed by observation of adverse events monitored for the type, frequency and intensity during the days of the follow-up.; The evaluation of the heart frequency will also be a safety parameter.	2 days