Trials / Completed
CompletedNCT00446056
Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)
Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 188 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 6 Years – 14 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MK0476, montelukast sodium / Duration of Treatment: 4 Weeks | |
| DRUG | Comparator: ketotifen / Duration of Treatment: 4 Weeks |
Timeline
- Start date
- 2003-09-25
- Primary completion
- 2004-06-16
- Completion
- 2004-06-16
- First posted
- 2007-03-12
- Last updated
- 2024-08-15
Source: ClinicalTrials.gov record NCT00446056. Inclusion in this directory is not an endorsement.