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Efficacy and Safety of Pediatric Drugs in Nasal Congestion

Sponsor
EMS (Industry)
Overall Status
Completed
CT.gov ID
NCT02601235
Collaborator
(none)
292
Enrollment
1
Location
2
Arms
14.5
Actual Duration (Months)
20.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
292 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of Safety and Efficacy of Pediatric Naridrin in Comparison to Afrin on the Improval of Nasal Congestion.
Actual Study Start Date :
Jan 16, 2018
Actual Primary Completion Date :
Aug 3, 2018
Actual Study Completion Date :
Apr 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Naridrin

Naridrin: 2 drops in each nostril once daily as prescription

Drug: Naridrin
Naridrin® : 2 drops in each nostril once daily as prescription
Other Names:
  • Naphazoline Hydrochloride
  • Mepyramine Maleate
  • Dexpanthenol

    		•
    Active Comparator: 0.05 % Oxymetazoline Hydrochloride

    2 pumps in each nostril every 12 hours

    Drug: Afrin
    2 pumps in each nostril every 12 hours.
    Other Names:
  • oxymetazoline hydrochloride

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Relief of Nasal Congestion [2 days]

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

    Secondary Outcome Measures

    1. Adverse Events [2 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculdade de Medicina do ABC Santo André SP Brazil

    Sponsors and Collaborators

    • EMS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    EMS
    ClinicalTrials.gov Identifier:
    NCT02601235
    Other Study ID Numbers:
    • NMDEMS0214NA-III
    First Posted:
    Nov 10, 2015
    Last Update Posted:
    Oct 16, 2019
    Last Verified:
    Oct 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by EMS
    nasal congestion
    Additional relevant MeSH terms:
    Pyrilamine
    Phenylephrine
    Oxymetazoline
    Naphazoline

    Study Results

    No Results Posted as of Oct 16, 2019