At a glance
ClinicalIndex Comparison RecordN/ACompleted· 256 enrolled
Drug / intervention
montelukast sodium +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Aged 6 to 24 Months With Asthma
In Brief
A clinical study evaluating montelukast sodium and Comparator: Placebo for Asthma. Completed, enrolled 256 participants.
Detailed Summary
A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
Collaborators--
Timeline
N/ACompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2000
Primary CompletionFeb 2001
First PostedJul 2009
TodayJul 2026
First PostedJul 22, 2009
Enrollment StartAug 1, 2000
Primary CompletionFeb 1, 2001
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.9 years ago
Interventions
montelukast sodiumdrug
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
Comparator: Placebodrug
Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks