Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-24 @ 5:00 AM
Study NCT ID:
NCT02601235
Status:
COMPLETED
Last Update Posted:
2019-10-16
First Post:
2015-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Pediatric Drugs in Nasal Congestion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015508', 'term': 'Nasal Obstruction'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009278', 'term': 'Naphazoline'}, {'id': 'D011738', 'term': 'Pyrilamine'}, {'id': 'C007288', 'term': 'dexpanthenol'}, {'id': 'D010109', 'term': 'Oxymetazoline'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000631', 'term': 'Aminopyridines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-14', 'studyFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2015-11-09', 'lastUpdatePostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relief of Nasal Congestion', 'timeFrame': '2 days', 'description': 'Relief of nasal congestion will be measured on a scale of 0 to 3 (0 = without congestion and 3 total congestion)'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '2 days', 'description': '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.\n\nThe evaluation of the heart frequency will also be a safety parameter.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nasal congestion'], 'conditions': ['Nasal Congestion']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of the Naridrin in improving nasal congestion.', 'detailedDescription': 'Open label, randomized, multicenter clinical study. Maximal experiment duration: 2 days; 2 visits. Safety and efficacy evaluation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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);\n* Signed Consent;\n* Participants whose mother, father and / or legal guardian is in accordance with all study purposes and procedures;\n* Participants with clinical symptoms of nasal congestion in at least one nostril diagnosed through the Glatzel mirror;\n* Participants with minimal score of 2 points in the 0 to 3 scale (Moderate obstruction).\n\nExclusion Criteria:\n\n* Participation in clinical trial in the year prior to this study;\n* Total obstruction of one of the nostrils by other etiologies that are not inflammatory or allergic;\n* Infectious bacterial-disease (clinically diagnosed);\n* Participants treated with antibiotic or possible antibiotic use due to another medical condition;\n* 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;\n* Use of decongestants or antihistamine (intranasal or systemic) in the 03 days prior to the study;\n* Use of inhaled drugs (except nasal moisturizers such as saline solution) or treatment with immunosuppressants in the week before the study;\n* Participants with septum deviation grade II and III, nasal polyps, severe turbinate hypertrophy, adenoid hypertrophy, or other determining factors for nasal obstruction;\n* History of hyperthyroidism or hypertension;\n* History of hypersensitivity to the components of the study drugs;\n* History of transphenoidal hypophysectomy or oronasal surgery with exposure of the dura-mater;\n* Exclusive mouth-breathers patients;\n* Participants in chronic drug treatment for allergies (eg vaccines for allergy, cromolyn);\n* History of alcohol and / or drug abuse 3 months prior to the study;\n* Smokers\n* Pregnancy or risk of pregnancy and lactating patients;\n* PAny clinical, laboratory that, in the judgment of the investigator, may interfere with the safety of research participants.'}, 'identificationModule': {'nctId': 'NCT02601235', 'briefTitle': 'Efficacy and Safety of Pediatric Drugs in Nasal Congestion', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'Clinical Evaluation of Safety and Efficacy of Pediatric Naridrin in Comparison to Afrin on the Improval of Nasal Congestion.', 'orgStudyIdInfo': {'id': 'NMDEMS0214NA-III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naridrin', 'description': 'Naridrin: 2 drops in each nostril once daily as prescription', 'interventionNames': ['Drug: Naridrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.05 % Oxymetazoline Hydrochloride', 'description': '2 pumps in each nostril every 12 hours', 'interventionNames': ['Drug: Afrin']}], 'interventions': [{'name': 'Naridrin', 'type': 'DRUG', 'otherNames': ['Naphazoline Hydrochloride', 'Mepyramine Maleate', 'Dexpanthenol'], 'description': 'Naridrin® : 2 drops in each nostril once daily as prescription', 'armGroupLabels': ['Naridrin']}, {'name': 'Afrin', 'type': 'DRUG', 'otherNames': ['oxymetazoline hydrochloride'], 'description': '2 pumps in each nostril every 12 hours.', 'armGroupLabels': ['0.05 % Oxymetazoline Hydrochloride']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Faculdade de Medicina do ABC', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}