CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 190 enrolled
Drug / intervention
montelukast sodium +1 moredrug
Likely dose
montelukast sodium 4 mgfrom 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.

Search/NCT00943397
NCT00943397Phase 3Completed
CompareCT.gov

A Multicenter, Open-Label, Controlled, Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma

Organon and Co·interventional·Posted Jul 22, 2009·Updated Feb 3, 2022

In Brief

A Phase 3 clinical trial evaluating montelukast sodium and Comparator: Usual Care for Asthma. Completed, enrolled 190 participants.

Detailed Summary

Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2009
Enrollment StartApr 1, 2001
Primary CompletionOct 1, 2001
Study CompletionNov 1, 2001
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.9 years ago

Interventions

montelukast sodiumdrug

Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks

Comparator: Usual Caredrug

Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks