CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,162 enrolled
Drug / intervention
montelukast +1 moredrug
Likely dose
Montelukast 5 mg chewable tablet once daily for 8 weeksAI-extracted
Key inclusion· 3
  • ✓Ages 6 to 14 years
  • ✓Chronic asthma with documented history requiring treatment within 6 months before study start
  • ✓At least one asthma exacerbation associated with a cold in the past year
Key exclusion· 2
  • ✕Any other acute or chronic pulmonary disorder
  • ✕Hospitalization for asthma more than three times within one year prior to enrollment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00461032
NCT00461032Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Group 8-week Study to Evaluate the Efficacy and Safety of Chewable Montelukast When Initiated at the Start of the School Year in Pediatric Patients With Chronic Asthma

Organon and Co·interventional·Posted Apr 17, 2007·Updated Feb 2, 2022

In Brief

A Phase 3 clinical trial evaluating montelukast and Comparator: Placebo for Asthma. Completed, enrolled 1,162 participants.

Detailed Summary

This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.

Study Details

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

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2007
Enrollment StartJun 1, 2006
Primary CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 19.2 years ago

Interventions

montelukastdrug

montelukast 5 mg tablet Once a day (QD) for 8 weeks

Comparator: Placebodrug

Placebo to montelukast QD for 8 weeks