Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-31 @ 9:40 PM
Study NCT ID:
NCT01533220
Status:
COMPLETED
Last Update Posted:
2019-01-25
First Post:
2012-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010632', 'term': 'Pheniramine'}, {'id': 'C007288', 'term': 'dexpanthenol'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2014-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-24', 'studyFirstSubmitDate': '2012-02-09', 'studyFirstSubmitQcDate': '2012-02-10', 'lastUpdatePostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay', 'timeFrame': '3 days', 'description': 'The individual response rate to the nasal congestion reduction is calculated by measuring the peak flow nasal inspiratory (PFNI) during the first and last visit.'}], 'secondaryOutcomes': [{'measure': 'Safety will be evaluated by the Adverse events occurence', 'timeFrame': '3 days', 'description': 'Adverse events will be collected and followed in order to evaluate safety and tolerability'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nasal and nasopharyngeal congestion'], 'conditions': ['Flu', 'Cold', 'Allergic Disorder of Respiratory System']}, 'descriptionModule': {'briefSummary': 'The common cold is a major cause of nasal obstruction and reaches children and adults two or more times a year. At the moment, there is no cure for the common cold, and therefore the reduction of symptoms is the focus of the treatment.\n\nThe study has parallel distribution design, with two equal groups, in which one group will be treated by a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.', 'detailedDescription': 'STUDY DESIGN\n\n* randomized,double blind, prospective, multicentric, parallel group, intent to treat trial\n* Experiment duration: 3 days\n* 2 visits (days 0 and 2)\n* Evaluation of symptoms reduction\n* Adverse events evaluation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must be able to understand the study procedures, agree to participate and give written consent.\n2. Patients aged over 18 years of both sexes;\n3. Patients with clinical signs of flu and colds or other upper respiratory allergies;\n4. Patients with early signs and symptoms with time of evolution not more than 72 hours.\n\nExclusion Criteria:\n\n1. Patients treated with antibiotics\n2. Current treatment with immunosuppressants (eg.cyclosporine or methotrexate);\n3. Use of intranasal cromalin the week before inclusion;\n4. Use of decongestants or anti-histaminic (intranasal or systemic);\n5. Presence of any disease or anatomical abnormality that may difficult the data analysis ;\n6. Uncontrolled hypertension;\n7. Presence of respiratory symptoms for more than 14 days;\n8. History of abuse of drugs and alcohol;\n9. Presence of other concomitant pulmonary diseases;\n10. Hypersensitivity to any compound of investigational product'}, 'identificationModule': {'nctId': 'NCT01533220', 'briefTitle': 'Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'A Randomized, Double-blind, Prospective, Multicentric, Superior Efficacy and Safety of Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal Due to Colds or Other Upper Respiratory Allergies', 'orgStudyIdInfo': {'id': 'NMPEMS1011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group', 'description': 'Naphazoline Hydrocloride (1.0mg) + Pheniramine Maleate (0.2mg) + Panthenol(5.0mg).\n\n02 drops in each nostril every 12 hours for 3 days', 'interventionNames': ['Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator group', 'description': 'Naphazoline Hydrocloride (0.5mg)\n\n02 drops in each nostril every 12 hours for 3 days', 'interventionNames': ['Drug: naphazoline hydrocloride']}], 'interventions': [{'name': 'naphazoline hydrocloride', 'type': 'DRUG', 'description': '02 drops into each nostril, 04 times a day for 03 days', 'armGroupLabels': ['Comparator group']}, {'name': 'Naphazoline hydrocloride + Pheniramine Maleate + Panthenol', 'type': 'DRUG', 'description': '02 drops into each nostril each 12 hours for 03 days', 'armGroupLabels': ['Test group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}