Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT00963469
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2009-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], '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': {'email': 'ClinicalTrialsDisclosure@merck.com', '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': 'During the 4 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.', 'description': 'The number of patients listed in the Adverse Event (AE) tables (448 montelukast group, 180 loratadine group and 451 in placebo group) is the number of patients who received study treatment.\n\nAlthough a patient may have had two or more clinical AEs the patient is counted only once in a category. The same patient may appear in different categories.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks', 'otherNumAtRisk': 451, 'otherNumAffected': 22, 'seriousNumAtRisk': 451, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Montelukast', 'description': 'Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks', 'otherNumAtRisk': 448, 'otherNumAffected': 27, 'seriousNumAtRisk': 448, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Loratadine', 'description': 'Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks', 'otherNumAtRisk': 180, 'otherNumAffected': 12, 'seriousNumAtRisk': 180, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 448, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MERCK CRISP Dict.'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 448, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MERCK CRISP Dict.'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 451, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 448, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MERCK CRISP Dict.'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'OG001', 'title': 'Montelukast', 'description': 'Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'OG002', 'title': 'Loratadine', 'description': 'Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'groupId': 'OG000', 'lowerLimit': '-0.28', 'upperLimit': '-0.18'}, {'value': '-0.33', 'groupId': 'OG001', 'lowerLimit': '-0.37', 'upperLimit': '-0.28'}, {'value': '-0.45', 'groupId': 'OG002', 'lowerLimit': '-0.52', 'upperLimit': '-0.37'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)', 'description': 'Mean change from baseline in Daytime Nasal Symptoms Score.\n\nPatients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale \\[Score 0 (best) to 3 (worse)\\]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'OG001', 'title': 'Montelukast', 'description': 'Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'OG002', 'title': 'Loratadine', 'description': 'Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'groupId': 'OG000', 'lowerLimit': '-0.23', 'upperLimit': '-0.14'}, {'value': '-0.28', 'groupId': 'OG001', 'lowerLimit': '-0.32', 'upperLimit': '-0.23'}, {'value': '-0.25', 'groupId': 'OG002', 'lowerLimit': '-0.32', 'upperLimit': '-0.19'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)', 'description': 'Mean change from baseline in Nighttime Symptoms Score.\n\nPatients were asked to rate each symptom daily on a 4-point scale \\[Score 0 (best) to 3 (worse)\\], and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'OG001', 'title': 'Montelukast', 'description': 'Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'OG002', 'title': 'Loratadine', 'description': 'Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '-0.16'}, {'value': '-0.30', 'groupId': 'OG001', 'lowerLimit': '-0.35', 'upperLimit': '-0.26'}, {'value': '-0.36', 'groupId': 'OG002', 'lowerLimit': '-0.43', 'upperLimit': '-0.30'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)', 'description': 'Composite Symptoms Scores were computed as the average of Daytime Nasal Scores \\[Score 0 (best) to 3 (worst)\\] and Nighttime Symptoms Scores \\[Score 0 (best) to 3 (worst)\\].', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'OG001', 'title': 'Montelukast', 'description': 'Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'OG002', 'title': 'Loratadine', 'description': 'Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'groupId': 'OG000', 'lowerLimit': '-0.23', 'upperLimit': '-0.14'}, {'value': '-0.28', 'groupId': 'OG001', 'lowerLimit': '-0.33', 'upperLimit': '-0.23'}, {'value': '-0.33', 'groupId': 'OG002', 'lowerLimit': '-0.41', 'upperLimit': '-0.26'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)', 'description': 'Mean change from baseline in Daytime Eye Symptoms scores.\n\nPatients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale \\[Score 0 (best) to 3 (worst)\\]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included'}, {'type': 'SECONDARY', 'title': "Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'OG001', 'title': 'Montelukast', 'description': 'Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'OG002', 'title': 'Loratadine', 'description': 'Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.73', 'groupId': 'OG000', 'lowerLimit': '2.59', 'upperLimit': '2.88'}, {'value': '2.43', 'groupId': 'OG001', 'lowerLimit': '2.29', 'upperLimit': '2.57'}, {'value': '2.30', 'groupId': 'OG002', 'lowerLimit': '2.08', 'upperLimit': '2.52'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'After first 2 weeks of treatment', 'description': 'An evaluation by the patient, administered after the first 2 weeks of treatment using a 7-point scale \\[Score 0 (best) to 6 (worst)\\], of the change in symptoms as compared to the beginning of the study.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.'}, {'type': 'SECONDARY', 'title': "Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '424', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'OG001', 'title': 'Montelukast', 'description': 'Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'OG002', 'title': 'Loratadine', 'description': 'Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.75', 'groupId': 'OG000', 'lowerLimit': '2.62', 'upperLimit': '2.88'}, {'value': '2.36', 'groupId': 'OG001', 'lowerLimit': '2.23', 'upperLimit': '2.50'}, {'value': '2.38', 'groupId': 'OG002', 'lowerLimit': '2.18', 'upperLimit': '2.59'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'After first 2 weeks of treatment', 'description': 'An evaluation by the physician, administered after the first 2 weeks of treatment using a 7-point scale \\[Score 0 (best) to 6 (worst)\\], of the change in symptoms as compared to the beginning of the study.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'OG001', 'title': 'Montelukast', 'description': 'Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'OG002', 'title': 'Loratadine', 'description': 'Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.55', 'groupId': 'OG000', 'lowerLimit': '-0.65', 'upperLimit': '-0.45'}, {'value': '-0.85', 'groupId': 'OG001', 'lowerLimit': '-0.94', 'upperLimit': '-0.75'}, {'value': '-0.85', 'groupId': 'OG002', 'lowerLimit': '-1.00', 'upperLimit': '-0.70'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)', 'description': 'Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale \\[0(best) to 6(worst)\\] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'FG001', 'title': 'Montelukast', 'description': 'Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'FG002', 'title': 'Loratadine', 'description': 'Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '451'}, {'groupId': 'FG001', 'numSubjects': '448'}, {'groupId': 'FG002', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '410'}, {'groupId': 'FG001', 'numSubjects': '420'}, {'groupId': 'FG002', 'numSubjects': '170'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Pre-randomization Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Site closed (local pollen Season ended)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Forty-seven study centers in the United States.\n\nPrime Therapy Period: August 2001 to November 2001', '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': '451', 'groupId': 'BG000'}, {'value': '448', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '1079', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'BG001', 'title': 'Montelukast', 'description': 'Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks'}, {'id': 'BG002', 'title': 'Loratadine', 'description': 'Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.9', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '82'}, {'value': '35.5', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '82'}, {'value': '38.7', 'groupId': 'BG002', 'lowerLimit': '15', 'upperLimit': '79'}, {'value': '36.2', 'groupId': 'BG003', 'lowerLimit': '15', 'upperLimit': '82'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '721', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '358', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Composite Symptoms Score', 'classes': [{'categories': [{'measurements': [{'value': '1.94', 'spread': '0.46', 'groupId': 'BG000'}, {'value': '1.98', 'spread': '0.47', 'groupId': 'BG001'}, {'value': '2.03', 'spread': '0.46', 'groupId': 'BG002'}, {'value': '1.97', 'spread': '0.46', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Composite Symptoms Scores were computed as the average of Daytime Nasal Scores (Score 0 (best) to 3 (worst)) and Nighttime Symptoms Scores \\[Score 0 (best) to 3 (worst)\\].', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Daytime Eye Symptoms score', 'classes': [{'categories': [{'measurements': [{'value': '1.61', 'spread': '0.81', 'groupId': 'BG000'}, {'value': '1.64', 'spread': '0.73', 'groupId': 'BG001'}, {'value': '1.64', 'spread': '0.78', 'groupId': 'BG002'}, {'value': '1.63', 'spread': '0.77', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale \\[Score 0 (best) to 3 (worst)\\]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Daytime Nasal Symptoms Score', 'classes': [{'categories': [{'measurements': [{'value': '2.16', 'spread': '0.44', 'groupId': 'BG000'}, {'value': '2.20', 'spread': '0.46', 'groupId': 'BG001'}, {'value': '2.23', 'spread': '0.44', 'groupId': 'BG002'}, {'value': '2.19', 'spread': '0.45', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Daytime Nasal Symptoms Score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale \\[Score 0 (best) to 3 (worse)\\]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nighttime Symptoms Score', 'classes': [{'categories': [{'measurements': [{'value': '1.65', 'spread': '0.64', 'groupId': 'BG000'}, {'value': '1.69', 'spread': '0.64', 'groupId': 'BG001'}, {'value': '1.77', 'spread': '0.63', 'groupId': 'BG002'}, {'value': '1.69', 'spread': '0.64', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Nighttime Symptoms Score. Patients were asked to rate each symptom of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point scale \\[Score 0 (best) to 3 (worse)\\], and the average score of the 3 symptoms was reported as the Nighttime Symptoms Score.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Rhinoconjunctivitis Quality of Life Score', 'classes': [{'categories': [{'measurements': [{'value': '3.37', 'spread': '1.02', 'groupId': 'BG000'}, {'value': '3.41', 'spread': '1.00', 'groupId': 'BG001'}, {'value': '3.46', 'spread': '1.08', 'groupId': 'BG002'}, {'value': '3.40', 'spread': '1.02', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale \\[0(best) to 6(worst)\\] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score.', 'unitOfMeasure': 'Scores 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': 1079}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2001-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-01', 'studyFirstSubmitDate': '2009-08-19', 'resultsFirstSubmitDate': '2009-09-16', 'studyFirstSubmitQcDate': '2009-08-20', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-05-12', 'studyFirstPostDateStruct': {'date': '2009-08-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period', 'timeFrame': 'Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)', 'description': 'Mean change from baseline in Daytime Nasal Symptoms Score.\n\nPatients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale \\[Score 0 (best) to 3 (worse)\\]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period', 'timeFrame': 'Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)', 'description': 'Mean change from baseline in Nighttime Symptoms Score.\n\nPatients were asked to rate each symptom daily on a 4-point scale \\[Score 0 (best) to 3 (worse)\\], and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.'}, {'measure': 'Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period', 'timeFrame': 'Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)', 'description': 'Composite Symptoms Scores were computed as the average of Daytime Nasal Scores \\[Score 0 (best) to 3 (worst)\\] and Nighttime Symptoms Scores \\[Score 0 (best) to 3 (worst)\\].'}, {'measure': 'Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period', 'timeFrame': 'Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)', 'description': 'Mean change from baseline in Daytime Eye Symptoms scores.\n\nPatients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale \\[Score 0 (best) to 3 (worst)\\]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.'}, {'measure': "Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment", 'timeFrame': 'After first 2 weeks of treatment', 'description': 'An evaluation by the patient, administered after the first 2 weeks of treatment using a 7-point scale \\[Score 0 (best) to 6 (worst)\\], of the change in symptoms as compared to the beginning of the study.'}, {'measure': "Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment", 'timeFrame': 'After first 2 weeks of treatment', 'description': 'An evaluation by the physician, administered after the first 2 weeks of treatment using a 7-point scale \\[Score 0 (best) to 6 (worst)\\], of the change in symptoms as compared to the beginning of the study.'}, {'measure': 'Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period', 'timeFrame': 'Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)', 'description': 'Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale \\[0(best) to 6(worst)\\] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score.'}]}, 'conditionsModule': {'conditions': ['Seasonal Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '14616102', 'type': 'BACKGROUND', 'citation': 'van Adelsberg J, Philip G, Pedinoff AJ, Meltzer EO, Ratner PH, Menten J, Reiss TF; Montelukast Fall Rhinitis Study Group. Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period. Allergy. 2003 Dec;58(12):1268-76. doi: 10.1046/j.1398-9995.2003.00261.x.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has a history of seasonal allergic rhinitis that worsens during the study season\n* Patient is a nonsmoker\n* Patient is in good health physical and mental health\n\nExclusion Criteria:\n\n* Patient is hospitalized\n* Patient is a woman who is \\< 8 weeks postpartum or is breastfeeding\n* Patient plans to move or vacation away during the study\n* Patient has had any major surgery with in past 4 weeks\n* Patient is a current or past abuser of alcohol or illicit drugs'}, 'identificationModule': {'nctId': 'NCT00963469', 'briefTitle': 'Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis Over a 4-Week Treatment Period-Fall 2001', 'orgStudyIdInfo': {'id': '0476-240'}, 'secondaryIdInfos': [{'id': 'MK0476-240'}, {'id': '2009_647'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'montelukast', 'interventionNames': ['Drug: montelukast sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'loratadine', 'interventionNames': ['Drug: Comparator: loratadine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'placebo', 'interventionNames': ['Drug: Comparator: placebo']}], 'interventions': [{'name': 'montelukast sodium', 'type': 'DRUG', 'description': 'montelukast 10 mg tablet orally once daily in the morning for 4 weeks', 'armGroupLabels': ['1']}, {'name': 'Comparator: loratadine', 'type': 'DRUG', 'description': 'loratadine 10 mg tablet orally once daily in the morning for 4 weeks', 'armGroupLabels': ['2']}, {'name': 'Comparator: placebo', 'type': 'DRUG', 'description': 'placebo tablet orally once daily in the morning for 4 weeks', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}