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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00446056
Other study ID # 0476-379
Secondary ID 2007_010
Status Completed
Phase Phase 4
First received
Last updated
Start date September 25, 2003
Est. completion date June 16, 2004

Study information

Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 188
Est. completion date June 16, 2004
Est. primary completion date June 16, 2004
Accepts healthy volunteers No
Gender All
Age group 6 Years to 14 Years
Eligibility Inclusion Criteria: - Intermittent asthma, mild persistent asthma, moderate persistent asthma, or severe persistent asthma patients with 2 or more mild or moderate attacks at baseline Exclusion Criteria: - Patient using anti-asthma treatment or therapy including corticosteroids or oral anti-allergic drugs - Patient with complications that will impair the judgment of efficacy of this drug - Patient with convulsive disorders such as epilepsy or such a history - Patient with liver disease, renal impairment, heart disease or such other complication

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MK0476, montelukast sodium / Duration of Treatment: 4 Weeks

Comparator: ketotifen / Duration of Treatment: 4 Weeks


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Sankei N, Kenshi F, Susumu F, Shigemi Y. Cysteinyl leukotriene receptor 1 antagonist; monterukast on childhood bronchial asthma in multicenter comparative double-blind study (Phase IV) with ketotifen fumarate. J Clin Therapeut Med. 2005;21(6):605-636

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement of morning peak expiratory flow over first 2 weeks
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