Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
Study NCT ID:
NCT02953366
Status:
WITHDRAWN
Last Update Posted:
2020-11-04
First Post:
2016-11-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068656', 'term': 'Mometasone Furoate'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2016-11-01', 'studyFirstSubmitQcDate': '2016-11-01', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief.', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Safety will be evaluated by the adverse events occurrences', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Consent of the patient;\n* Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);\n\nExclusion Criteria:\n\n* Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;\n* Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;\n* Patients with history of hypersensitivity to any of the formula compounds;\n* Participation in clinical trial in the year prior to this study;\n* Pregnancy or risk of pregnancy and lactating patients;\n* Patients who were in use of drugs that can interfere with evaluation;\n* Decongestants dependent patients or patients receiving allergen specific immunotherapy;\n* Patients on treatment with monoamine oxidase inhibitors (MAOIs).'}, 'identificationModule': {'nctId': 'NCT02953366', 'briefTitle': 'Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermittent Allergic Rhinitis in Childrens', 'orgStudyIdInfo': {'id': 'EMS1215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EMS Mometasone gel', 'description': 'The patient should administer 1 spray in each nostril once daily.', 'interventionNames': ['Drug: EMS Mometasone gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mometasone spray nasal', 'description': 'The patient should administer 1 spray in each nostril once daily.', 'interventionNames': ['Drug: Mometasone spray nasal']}], 'interventions': [{'name': 'EMS Mometasone gel', 'type': 'DRUG', 'description': 'The patient should administer 1 spray in each nostril once daily.', 'armGroupLabels': ['EMS Mometasone gel']}, {'name': 'Mometasone spray nasal', 'type': 'DRUG', 'otherNames': ['Nasonex'], 'description': 'The patient should administer 1 spray in each nostril once daily.', 'armGroupLabels': ['Mometasone spray nasal']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}