Trials / Completed
CompletedNCT00394160
Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)
A Randomized, 3-Period, Multiple-Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Plasma Concentration Profile of Montelukast Administered Once Daily as Oral Granules in Children Aged 1 to 3 Months
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 1 Month – 3 Months
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 1 to \< 3 months of age with bronchiolitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MK0476, Montelukast Sodium /Duration of Treatment : 14 Days |
Timeline
- Start date
- 2004-12-01
- Primary completion
- 2005-10-01
- Completion
- 2005-10-01
- First posted
- 2006-10-31
- Last updated
- 2024-08-15
Source: ClinicalTrials.gov record NCT00394160. Inclusion in this directory is not an endorsement.