CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,771 enrolled
Drug / intervention
montelukast sodium +2 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/NCT00337675
NCT00337675Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years

Organon and Co·interventional·Posted Jun 16, 2006·Updated May 10, 2024

In Brief

A Phase 3 clinical trial evaluating montelukast sodium and Comparator: Placebo (unspecified) for Asthma. Completed, enrolled 1,771 participants.

Detailed Summary

This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).

Study Details

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

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 16, 2006
Enrollment StartOct 1, 2006
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.0 years ago

Interventions

montelukast sodiumdrug

Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.

Comparator: Placebo (unspecified)drug

Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.

montelukast sodiumdrug

Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.