Trials / Completed
CompletedNCT00289874
Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)
A Multicenter, Double-Blind, Placebo Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral Montelukast Versus Placebo in Persistent Asthma Which is Also Active During Allergy Seasons in Pediatric Patients With Seasonal Aeroallergen Sensitivity
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 421 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 6 Years – 14 Years
- Healthy volunteers
- Not accepted
Summary
This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | montelukast sodium | montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment. |
| DRUG | Comparator: Placebo | Placebo. Up to 3 weeks of treatment |
Timeline
- Start date
- 2006-03-01
- Primary completion
- 2007-07-01
- Completion
- 2007-07-01
- First posted
- 2006-02-10
- Last updated
- 2022-02-02
- Results posted
- 2010-10-01
Source: ClinicalTrials.gov record NCT00289874. Inclusion in this directory is not an endorsement.