Trials / Completed
CompletedNCT00968149
A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Age 2 Through 14 Years With Seasonal Allergic Rhinitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 413 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 2 Years – 14 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | montelukast sodium | one montelukast chewable tablet daily at bed time for 2 weeks, 4 mg for patients aged 2-5 years and 5 mg for patients 6-14 years |
| DRUG | Comparator: Placebo | one placebo chewable tablet daily at bed time for 2 weeks |
Timeline
- Start date
- 2001-03-01
- Primary completion
- 2001-06-01
- Completion
- 2001-07-01
- First posted
- 2009-08-28
- Last updated
- 2022-02-03
- Results posted
- 2009-12-11
Source: ClinicalTrials.gov record NCT00968149. Inclusion in this directory is not an endorsement.