Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT03238560
Status:
UNKNOWN
Last Update Posted:
2017-08-03
First Post:
2017-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Population Pharmacokinetics of Montelukast in Infants and Children
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-02', 'studyFirstSubmitDate': '2017-08-01', 'studyFirstSubmitQcDate': '2017-08-02', 'lastUpdatePostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma concentration', 'timeFrame': '3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration', 'description': 'To detect the plasma concentrations of montelukast at 3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration.'}, {'measure': 'bronchoalveolar lavage fluid(BALF)', 'timeFrame': 'Procedure (When the patient underwent fiberoptic bronchoscopy)', 'description': 'To detect the concentrations of montelukast in bronchoalveolar lavage fluid'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': "The investigators' aim was to evaluate the population pharmacokinetics of montelukast in infants and children and define the appropriate dose in order to optimize Montelukast treatment in this vulnerable population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients are cared in the department of pediatric respiratory at Shandong Provincial Qianfoshan Hospital, Jinan, China.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients have been diagnosed with asthma; age range: 1 month to 12 years old; montelukast used as part of regular treatment.\n\nExclusion Criteria:\n\n* expected survival time less than the treatment cycle; patients with other factors that researcher considers unsuitable for inclusion.'}, 'identificationModule': {'nctId': 'NCT03238560', 'briefTitle': 'The Population Pharmacokinetics of Montelukast in Infants and Children', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Population Pharmacokinetics of Montelukast in Infants and Children', 'orgStudyIdInfo': {'id': '2016Montelukast001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Montelukast Chewable Tablet', 'type': 'DRUG', 'description': 'Montelukast treatment was used at a dosage of 5mg/day once daily'}]}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': "Ji'nan", 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Zhao, Ph.D', 'role': 'CONTACT', 'email': 'zhao4wei2@hotmail.com', 'phone': '86053188383308'}], 'facility': 'Shandong Provincial Qianfoshan Hospital'}], 'centralContacts': [{'name': 'Wei Zhao, Ph.D', 'role': 'CONTACT', 'email': 'zhao4wei2@hotmail.com', 'phone': '86053188383308'}], 'overallOfficials': [{'name': 'Wei Zhao, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of department of clinical pharmacy and pharmacology', 'investigatorFullName': 'Wei Zhao', 'investigatorAffiliation': 'Shandong University'}}}}