Trials / Completed
CompletedNCT00117338
A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)
A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 276 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 6 Years – 14 Years
- Healthy volunteers
- Not accepted
Summary
This study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children will help resolve asthma attacks faster than using the current standard care alone.
Detailed description
The duration of treatment is a one time dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | montelukast sodium | Montelukast IV 5.25 mg lyophilized (reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chloride) for a study approximately 120 minutes in duration |
| DRUG | Comparator: placebo (unspecified) | Pbo for a study approximately 120 minutes in duration |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2008-03-01
- Completion
- 2008-03-01
- First posted
- 2005-07-06
- Last updated
- 2024-05-10
- Results posted
- 2009-08-11
Source: ClinicalTrials.gov record NCT00117338. Inclusion in this directory is not an endorsement.