Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)

NCT ID: NCT00446056

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-25
• Study Completion Date: 2004-06-16

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

MK0476, montelukast sodium / Duration of Treatment: 4 Weeks

Intervention Type: DRUG

Comparator: ketotifen / Duration of Treatment: 4 Weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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

Reference Type: RESULT

Other Identifiers

2007_010

Identifier Type: -

Identifier Source: secondary_id

0476-379

Identifier Type: -

Identifier Source: org_study_id