Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT00446056
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2007-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)
Sponsor:
Organon and Co
Organization:
Study Overview
Official Title:
Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate
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 clinical study evaluates the safety of montelukast and compares montelukast to ketotifen, used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over first 2 weeks in patients with pediatric bronchial asthma aged 6 to \< 15.
The effect of body weight on the efficacy and safety of montelukast will also be evaluated in this study.
The effect of body weight on the efficacy and safety of montelukast will also be evaluated in this study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007_010 | None | None | View |