Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00092092
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2004-09-21
Brief Title:
Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma MK-0476-254
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Double-Blind Double-Dummy Randomized Placebo-Controlled 2-Arm 2X2 Crossover Study Comparing the Effects of Montelukast Inhaled Budesonide and Placebo on Lower Leg Growth in Children Prepubertal Tanner Stage I With Mild Asthma
Status:
COMPLETED
Status Verified Date:
2022-02
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 determine the effect of montelukast an approved medication on the lower leg growth rate in children with mild asthma The primary hypothesis is that the lower leg length LLL growth rate for children treated with montelukast compared to placebo will be established
Detailed Description:
This is a crossover study that consists of a 2-week placebo run-in period then a first 3-week treatment period then a 2-week washout period and then a second 3-week treatment period Participants will be randomized to treatment with either montelukast and placebo or budesonide and placebo The duration of treatment is 6 weeks
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 |
|---|---|---|---|
| 2004_023 | OTHER | Telerx ID Number | None |