Clinical trial NCT02601235: Efficacy and Safety of Pediatric Drugs in Nasal Congestion
Official title: Clinical Evaluation of Safety and Efficacy of Pediatric Naridrin in Comparison to Afrin on the Improval of Nasal Congestion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasal Congestion
Keywords: nasal congestion
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2015-11-10
Enrollment: 292
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Relief of Nasal Congestion
timeFrame: 2 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 2 days
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: SP
Study officials:
References: