Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394160
Status:
COMPLETED
Last Update Posted:
2022-02-14
First Post:
2006-10-27
Brief Title:
Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis 0476-297
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006_544 | None | None | None |