Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 1:32 PM
Study NCT ID:
NCT01135134
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2010-05-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The investigator agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The Sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'MFNS', 'description': 'Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:\n\n* 5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.\n* 12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.', 'otherNumAtRisk': 220, 'otherNumAffected': 24, 'seriousNumAtRisk': 220, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo MFNS. Administration was as follows:\n\n* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.\n* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.', 'otherNumAtRisk': 113, 'otherNumAffected': 19, 'seriousNumAtRisk': 113, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Naspharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Total Nasal Symptom Score at 2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MFNS', 'description': 'Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:\n\n* 5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.\n* 12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo MFNS. Administration was as follows:\n\n* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.\n* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9850', 'spread': '0.1633', 'groupId': 'OG000'}, {'value': '-1.9081', 'spread': '0.2233', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 2 weeks (or discontinuation)', 'description': 'Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Total Nasal Symptom Score at 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MFNS', 'description': 'Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:\n\n* 5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.\n* 12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo MFNS. Administration was as follows:\n\n* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.\n* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4686', 'spread': '0.1441', 'groupId': 'OG000'}, {'value': '-1.1651', 'spread': '0.1967', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 1 week', 'description': 'Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MFNS', 'description': 'Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:\n\n* 5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.\n* 12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo MFNS. Administration was as follows:\n\n* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.\n* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did not meet protocol eligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MFNS', 'description': 'Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:\n\n* 5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.\n* 12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo MFNS. Administration was as follows:\n\n* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.\n* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Between 5 and 11 years', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}, {'title': 'Between 12 and 15 years', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 333}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2010-05-28', 'resultsFirstSubmitDate': '2011-10-14', 'studyFirstSubmitQcDate': '2010-05-28', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-10-14', 'studyFirstPostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Total Nasal Symptom Score at 2 Weeks', 'timeFrame': 'Baseline and 2 weeks (or discontinuation)', 'description': 'Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Total Nasal Symptom Score at 1 Week', 'timeFrame': 'Baseline and 1 week', 'description': 'Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rhinitis, Allergic, Perennial']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Okamoto Y, Suzuki I . Multicenter, double-blind, randomized, placebo-controlled study of mometasone furoate nasal spray in Japanese pediatric subjects with perennial allergic rhinitis . Oto-rhino Laryngol Tokyo. 2013;106(11):1045-1057.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate (MF) in pediatric subjects with perennial allergic rhinitis. The subjects 5 to 15 years of age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days at minimum and eligibility for inclusion in this study will be assessed. Following the observation period, eligible subjects will be randomized to MF or MF placebo for a 2-week double-blind treatment. At each clinic visit (at the start of treatment and after 1 and 2 weeks of treatment or at discontinuation), nasal symptom scores, nasal findings, and adverse events (AEs), will be evaluated. A 30-day follow-up visit will take place after the completion (or discontinuation) of the 2-week treatment period, to confirm presence or absence of serious adverse events (SAEs) and trial procedure-related AEs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric subjects with perennial allergic rhinitis who satisfy all of the following main criteria:\n\n * Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, after the pretreatment observation period.\n * Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust-mite antigen).\n * Male or female outpatients aged 5 to 15 years at the time of providing informed consent.\n\nExclusion Criteria:\n\n* Subjects for whom any of the main exclusion criteria below is applicable will not be registered in this study.\n\n * Subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment at the time of registration\n * Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics\n * Subjects with repeated epistaxis\n * Subjects who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed\n * Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor\n * Subjects with complication of vasomotor rhinitis or eosinophilic rhinitis.\n * Subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.'}, 'identificationModule': {'nctId': 'NCT01135134', 'briefTitle': 'Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No.P06332)', 'orgStudyIdInfo': {'id': 'P06332'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mometasone furoate nasal spray (MFNS) (50 μg spray device)', 'description': 'The dose will be as follows:\n\n* 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks\n* 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks', 'interventionNames': ['Drug: Mometasone furoate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'MF placebo nasal spray', 'description': 'Administration will be as follows:\n\n* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks\n* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Mometasone furoate', 'type': 'DRUG', 'otherNames': ['Nasonex'], 'description': 'The study drug is MFNS (50 μg spray device) and the dose will be:\n\n* 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks\n* 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks', 'armGroupLabels': ['Mometasone furoate nasal spray (MFNS) (50 μg spray device)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'MF Placebo nasal spray and administration will be as follows:\n\n* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks\n* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks', 'armGroupLabels': ['MF placebo nasal spray']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}