Trials / Completed
CompletedNCT00461032
Montelukast Back to School Asthma Study (0476-340)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,162 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 6 Years – 14 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | montelukast | montelukast 5 mg tablet Once a day (QD) for 8 weeks |
| DRUG | Comparator: Placebo | Placebo to montelukast QD for 8 weeks |
Timeline
- Start date
- 2006-06-01
- Primary completion
- 2006-11-01
- Completion
- 2006-11-01
- First posted
- 2007-04-17
- Last updated
- 2022-02-02
- Results posted
- 2010-02-04
Source: ClinicalTrials.gov record NCT00461032. Inclusion in this directory is not an endorsement.