Clinical trial
Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)
NCT00394160 · Organon and Co, Industry · Completed
Key facts
| NCT number | NCT00394160 |
|---|---|
| Title | Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297) |
| Official title | 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 |
| Lead sponsor | Organon and Co, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Bronchiolitis |
| Intervention type | Drug |
| Interventions | MK0476, Montelukast Sodium /Duration of Treatment : 14 Days |
| Enrollment | 12 |
| Start date | Dec 1, 2004 |
| Primary completion | Oct 1, 2005 |
| Completion | Oct 1, 2005 |
| First posted | Oct 31, 2006 |
| Last update posted | Aug 15, 2024 |
At a glance
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: