At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 689 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 Chronic Asthma Study Comparing Montelukast With Placebo in 2- to 5-Year-Old Patients
In Brief
A Phase 3 clinical trial evaluating montelukast sodium and Comparator: Placebo for Asthma. Completed, enrolled 689 participants.
Detailed Summary
A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 1997
Primary CompletionMar 2001
First PostedAug 2009
TodayJul 2026
First PostedAug 28, 2009
Enrollment StartDec 1, 1997
Primary CompletionMar 1, 2001
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.8 years ago
Interventions
montelukast sodiumdrug
one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks
Comparator: Placebodrug
one chewable placebo tablet, once daily at bedtime for 12 weeks