The Population Pharmacokinetics of Montelukast in Infants and Children

NCT ID: NCT03238560

Last Updated: 2017-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-01

Study Completion Date

2018-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Montelukast Chewable Tablet

Montelukast treatment was used at a dosage of 5mg/day once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients have been diagnosed with asthma; age range: 1 month to 12 years old; montelukast used as part of regular treatment.

Exclusion Criteria

* expected survival time less than the treatment cycle; patients with other factors that researcher considers unsuitable for inclusion.
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Wei Zhao

Head of department of clinical pharmacy and pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Zhao, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shandong University

Locations

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Shandong Provincial Qianfoshan Hospital

Ji'nan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Zhao, Ph.D

Role: CONTACT

86053188383308

Facility Contacts

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Wei Zhao, Ph.D

Role: primary

86053188383308

Other Identifiers

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2016Montelukast001

Identifier Type: -

Identifier Source: org_study_id

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