Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT00733005
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2008-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck, Sharp & Dohme Corp.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mometasone Furoate Nasal Spray', 'description': 'Mometasone furoate nasal spray 200 mcg QD (once per day)', 'otherNumAtRisk': 162, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Nasal Spray', 'description': 'Matching placebo nasal spray', 'otherNumAtRisk': 162, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray', 'description': 'Mometasone furoate nasal spray 200 mcg QD (once per day)'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Matching placebo nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.102', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '15 days of treatment', 'description': "Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours \\[reflective\\])", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Standard deviation is pooled.'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray', 'description': 'Mometasone furoate nasal spray 200 mcg QD (once per day)'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Matching placebo nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.61', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '-2.06', 'spread': '2.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '15 days of treatment', 'description': 'Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Standard deviation is pooled.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mometasone Furoate Nasal Spray', 'description': 'Mometasone furoate nasal spray 200 mcg QD (once per day)'}, {'id': 'FG001', 'title': 'Placebo Nasal Spray', 'description': 'Matching placebo nasal spray'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '162'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Treatment Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mometasone Furoate Nasal Spray', 'description': 'Mometasone furoate nasal spray 200 mcg QD (once per day)'}, {'id': 'BG001', 'title': 'Placebo Nasal Spray', 'description': 'Matching placebo nasal spray'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '95', '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': 324}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2008-08-08', 'resultsFirstSubmitDate': '2009-10-13', 'studyFirstSubmitQcDate': '2008-08-08', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-10-13', 'studyFirstPostDateStruct': {'date': '2008-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.', 'timeFrame': '15 days of treatment', 'description': "Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours \\[reflective\\])"}], 'secondaryOutcomes': [{'measure': 'The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days', 'timeFrame': '15 days of treatment', 'description': 'Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A subject must be 12 years of age or older, of either sex, and of any race.\n* A subject must have at least a 2-year history of SAR which exacerbates during the study season.\n* A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.\n* A subject must be clinically symptomatic at the Screening and Baseline Visits.\n\nExclusion Criteria:\n\n* A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.\n* A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.\n* A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.\n* A subject who is participating in any other clinical study.\n* A subject who is part of the staff personnel directly involved with this study.\n* A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.\n* A female subject who is breast-feeding, pregnant, or intends to become pregnant.\n* A subject previously randomized into this study.\n* A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.'}, 'identificationModule': {'nctId': 'NCT00733005', 'briefTitle': 'Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)', 'orgStudyIdInfo': {'id': 'P05528'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Mometasone furoate nasal spray 200 mcg QD (once per day)', 'interventionNames': ['Drug: Mometasone furoate nasal spray (MFNS)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'description': 'Matching placebo nasal spray', 'interventionNames': ['Drug: Matching placebo nasal spray']}], 'interventions': [{'name': 'Mometasone furoate nasal spray (MFNS)', 'type': 'DRUG', 'otherNames': ['Nasonex Nasal Spray'], 'description': 'MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days', 'armGroupLabels': ['Arm 1']}, {'name': 'Matching placebo nasal spray', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days', 'armGroupLabels': ['Arm 2']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}