Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-31 @ 3:40 PM
Study NCT ID:
NCT00700661
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2008-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093875', 'term': 'montelukast'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2002-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2008-06-17', 'studyFirstSubmitQcDate': '2008-06-18', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'asthma episodes in 2 - 5 year old children', 'timeFrame': 'at 12 months'}], 'secondaryOutcomes': [{'measure': 'the number of treatments and duration of asthma episodes', 'timeFrame': 'at 12 months'}]}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '15542792', 'type': 'BACKGROUND', 'citation': 'Bisgaard H, Zielen S, Garcia-Garcia ML, Johnston SL, Gilles L, Menten J, Tozzi CA, Polos P. Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma. Am J Respir Crit Care Med. 2005 Feb 15;171(4):315-22. doi: 10.1164/rccm.200407-894OC. Epub 2004 Nov 12.'}]}, 'descriptionModule': {'briefSummary': 'A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female between and including the ages of 2 and 5 years\n* Patient was treated with steroids for an asthma episode in the last 3 months\n* Patient was admitted to the hospital or emergency room in the last 3 months\n* Patient is able to chew a tablet\n\nExclusion Criteria:\n\n* Patient has been in a research study in the past 4 weeks\n* Patient has visited the emergency room for an asthma episode in the past week\n* Patients has a history of stomach, heart, liver, nerve, kidney or blood disease'}, 'identificationModule': {'nctId': 'NCT00700661', 'briefTitle': 'A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Study to Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years', 'orgStudyIdInfo': {'id': '0476-907'}, 'secondaryIdInfos': [{'id': 'MK0476-907'}, {'id': '2007_572'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Drug', 'interventionNames': ['Drug: montelukast']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Pbo', 'interventionNames': ['Drug: placebo (unspecified)']}], 'interventions': [{'name': 'montelukast', 'type': 'DRUG', 'otherNames': ['MK0476', 'SINGULAIR ®'], 'description': 'One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks', 'armGroupLabels': ['1']}, {'name': 'placebo (unspecified)', 'type': 'DRUG', 'description': 'Matching-image Montelukast placebo. Duration of Treatment: 48 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'}}}}