Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-02-17 @ 4:50 PM
Study NCT ID:
NCT00092092
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2004-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2004-09-21', 'studyFirstSubmitQcDate': '2004-09-23', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short-term lower-leg growth rate (LLGR)', 'timeFrame': 'Baseline and Week 3', 'description': 'Lower leg length was measured in millimeters (mm) using a knemometer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma, Bronchial']}, 'referencesModule': {'references': [{'pmid': '17659605', 'type': 'BACKGROUND', 'citation': 'Pedersen S, Agertoft L, Williams-Herman D, Kuznetsova O, Reiss TF, Knorr B, Dass SB, Wolthers OD. Placebo-controlled study of montelukast and budesonide on short-term growth in prepubertal asthmatic children. Pediatr Pulmonol. 2007 Sep;42(9):838-43. doi: 10.1002/ppul.20666.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of montelukast, an approved medication, on the lower leg growth rate in children with mild asthma. The primary hypothesis is that the lower leg length (LLL) growth rate for children treated with montelukast compared to placebo will be established.', 'detailedDescription': 'This is a crossover study that consists of a 2-week placebo run-in period, then a first 3-week treatment period, then a 2-week washout period, and then a second 3-week treatment period. Participants will be randomized to treatment with either montelukast and placebo or budesonide and placebo. The duration of treatment is 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A 6-month history of asthma with periodic episodes requiring treatment.\n\nExclusion Criteria:\n\n* Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.'}, 'identificationModule': {'nctId': 'NCT00092092', 'briefTitle': 'Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled, 2-Arm, 2X2 Crossover Study Comparing the Effects of Montelukast, Inhaled Budesonide, and Placebo on Lower Leg Growth in Children (Prepubertal, Tanner Stage I) With Mild Asthma', 'orgStudyIdInfo': {'id': '0476-254'}, 'secondaryIdInfos': [{'id': '2004_023', 'type': 'OTHER', 'domain': 'Telerx ID Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Montelukast→Placebo', 'description': 'Participants receive one montelukast 5 mg chewable tablet once daily (QD) for 3 weeks. After a 2-week washout period, participants receive one placebo chewable tablet QD for 3 weeks.', 'interventionNames': ['Drug: Montelukast chewable tablets', 'Drug: Placebo to montelukast chewable tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo→Montelukast', 'description': 'Participants receive one placebo chewable tablet QD for 3 weeks. After a 2-week washout period, participants receive one montelukast 5 mg chewable tablet QD for 3 weeks.', 'interventionNames': ['Drug: Montelukast chewable tablets', 'Drug: Placebo to montelukast chewable tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Budesonide→Placebo', 'description': 'Participants receive budesonide 200 mcg inhalation powder twice daily (BID) for 3 weeks. After a 2-week washout period, participants receive placebo inhalation powder BID for 3 weeks.', 'interventionNames': ['Drug: Budesonide inhaler', 'Drug: Placebo to budesonide inhaler']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo→Budesonide', 'description': 'Participants receive placebo inhalation powder BID for 3 weeks. After a 2-week washout period, participants receive budesonide 200 mcg inhalation powder BID for 3 weeks.', 'interventionNames': ['Drug: Budesonide inhaler', 'Drug: Placebo to budesonide inhaler']}], 'interventions': [{'name': 'Montelukast chewable tablets', 'type': 'DRUG', 'description': 'Montelukast sodium 5 mg chewable tablets', 'armGroupLabels': ['Montelukast→Placebo', 'Placebo→Montelukast']}, {'name': 'Budesonide inhaler', 'type': 'DRUG', 'description': 'Budesonide 200 mcg inhalation powder', 'armGroupLabels': ['Budesonide→Placebo', 'Placebo→Budesonide']}, {'name': 'Placebo to montelukast chewable tablets', 'type': 'DRUG', 'description': 'Placebo chewable tablets', 'armGroupLabels': ['Montelukast→Placebo', 'Placebo→Montelukast']}, {'name': 'Placebo to budesonide inhaler', 'type': 'DRUG', 'description': 'Placebo inhalation powder', 'armGroupLabels': ['Budesonide→Placebo', 'Placebo→Budesonide']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}