Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-28 @ 7:34 PM
Study NCT ID:
NCT00092118
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2004-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'C093875', 'term': 'montelukast'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected during the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.', 'description': 'The number of participants listed in the AE tables (990 placebo \\& 1002 montelukast) is the number that received treatment.\n\nAlthough a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.', 'otherNumAtRisk': 990, 'otherNumAffected': 0, 'seriousNumAtRisk': 990, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Montelukast 10 mg', 'description': 'Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.', 'otherNumAtRisk': 1002, 'otherNumAffected': 0, 'seriousNumAtRisk': 1002, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 990, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Joint Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Anxiety Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 990, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1002, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '980', 'groupId': 'OG000'}, {'value': '1000', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.'}, {'id': 'OG001', 'title': 'Montelukast 10 mg', 'description': 'Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.37', 'groupId': 'OG000', 'lowerLimit': '-0.40', 'upperLimit': '-0.34'}, {'value': '-0.44', 'groupId': 'OG001', 'lowerLimit': '-0.48', 'upperLimit': '-0.41'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 week treatment period (from baseline though the end of week 6)', 'description': 'Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale \\[Score 0 (best) to 3 (worst)\\].', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. All patients with efficacy measurements, both at baseline and during the treatment period were included.'}, {'type': 'SECONDARY', 'title': "Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'OG000'}, {'value': '977', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.'}, {'id': 'OG001', 'title': 'Montelukast 10 mg', 'description': 'Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.42', 'groupId': 'OG000', 'lowerLimit': '2.33', 'upperLimit': '2.51'}, {'value': '2.27', 'groupId': 'OG001', 'lowerLimit': '2.18', 'upperLimit': '2.35'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At the end of the 6 week treatment period', 'description': 'An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale \\[Score 0 (best) to 6 (worst)\\], in answer to a single question regarding the change in symptoms as compared to the beginning of the study.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no treatment period data were available.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'OG000'}, {'value': '977', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.'}, {'id': 'OG001', 'title': 'Montelukast 10 mg', 'description': 'Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.69', 'groupId': 'OG000', 'lowerLimit': '-0.76', 'upperLimit': '-0.62'}, {'value': '-0.84', 'groupId': 'OG001', 'lowerLimit': '-0.91', 'upperLimit': '-0.77'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale \\[Score 0 (best) to 6 (worst)\\] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no baseline or treatment period data were available'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.'}, {'id': 'FG001', 'title': 'Montelukast 10 mg', 'description': 'Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1 patient discontinued after randomization due to a adverse experience that began pre-randomization.', 'groupId': 'FG000', 'numSubjects': '990'}, {'comment': '2 patients discontinued after randomization due to adverse experience that began pre-randomization.', 'groupId': 'FG001', 'numSubjects': '1002'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '906'}, {'groupId': 'FG001', 'numSubjects': '913'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '89'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Patients were screened at 122 sites worldwide.\n\nPrimary therapy period: Oct 2003 to May 2004', 'preAssignmentDetails': 'Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime nasal symptoms score during the run-in period were excluded from randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '990', 'groupId': 'BG000'}, {'value': '1002', 'groupId': 'BG001'}, {'value': '1992', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.'}, {'id': 'BG001', 'title': 'Montelukast 10 mg', 'description': 'Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.6', 'spread': '13.12', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '13.61', 'groupId': 'BG001'}, {'value': '36.4', 'spread': '13.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '632', 'groupId': 'BG000'}, {'value': '644', 'groupId': 'BG001'}, {'value': '1276', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '358', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '716', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Daytime nasal symptoms score', 'classes': [{'categories': [{'measurements': [{'value': '2.10', 'spread': '0.41', 'groupId': 'BG000'}, {'value': '2.09', 'spread': '0.40', 'groupId': 'BG001'}, {'value': '2.10', 'spread': '0.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Computed using the average values of the 3 individual daytime nasal symptoms scores of congestion, rhinorrhea, and sneezing on a 4-point scale \\[Score 0 (best) to 3 (worst)\\]. Baseline is computed as the average daily value during the prerandomization run-in period (which included the 5-7 days prior to randomization at Visit 3).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Rhinoconjunctivitis Quality-of-Life Score', 'classes': [{'categories': [{'measurements': [{'value': '2.96', 'spread': '1.10', 'groupId': 'BG000'}, {'value': '2.94', 'spread': '1.04', 'groupId': 'BG001'}, {'value': '2.95', 'spread': '1.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Patients completed the validated, self-administered RQLQ which\n\nincluded 28 items on a 7-point scale \\[Score 0 (best) to 6 (worst)\\] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores within each domain were averaged, then the scores for the 7 domains were averaged to obtain the overall score. Baseline is the Visit 3 value.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1992}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-01', 'studyFirstSubmitDate': '2004-09-21', 'resultsFirstSubmitDate': '2009-09-10', 'studyFirstSubmitQcDate': '2004-09-23', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-06-29', 'studyFirstPostDateStruct': {'date': '2004-09-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis', 'timeFrame': '6 week treatment period (from baseline though the end of week 6)', 'description': 'Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale \\[Score 0 (best) to 3 (worst)\\].'}], 'secondaryOutcomes': [{'measure': "Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period", 'timeFrame': 'At the end of the 6 week treatment period', 'description': 'An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale \\[Score 0 (best) to 6 (worst)\\], in answer to a single question regarding the change in symptoms as compared to the beginning of the study.'}, {'measure': 'Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period', 'timeFrame': 'Baseline and Week 6', 'description': 'Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale \\[Score 0 (best) to 6 (worst)\\] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rhinitis, Allergic, Perennial']}, 'referencesModule': {'references': [{'pmid': '16400895', 'type': 'BACKGROUND', 'citation': 'Patel P, Philip G, Yang W, Call R, Horak F, LaForce C, Gilles L, Garrett GC, Dass SB, Knorr BA, Reiss TF. Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2005 Dec;95(6):551-7. doi: 10.1016/S1081-1206(10)61018-6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smoker with a 2-year documented history of perennial allergic (symptoms that persist throughout the year) rhinitis symptoms and positive allergy testing\n\nExclusion Criteria:\n\n* Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection'}, 'identificationModule': {'nctId': 'NCT00092118', 'briefTitle': 'The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis', 'orgStudyIdInfo': {'id': '0476-265'}, 'secondaryIdInfos': [{'id': 'MK0476-265'}, {'id': '2004_018'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Montelukast', 'interventionNames': ['Drug: Montelukast']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Comparator: Placebo']}], 'interventions': [{'name': 'Montelukast', 'type': 'DRUG', 'description': 'one 10 mg tablet, taken once daily at bed time for 6 weeks', 'armGroupLabels': ['1']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'one placebo tablet, taken once daily at bed time for 6 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}