Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446056
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2007-03-09
Brief Title:
Montelukast Post-Marketing Comparative Study With Ketotifen 0476-379
Sponsor:
Organon and Co
Organization:
Organon and Co
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:
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 |
|---|---|---|---|
| 2007_010 | None | None | None |