NCT00446056

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_4 asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2004

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2007

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

March 9, 2007

Last Update Submit

August 12, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Improvement of morning peak expiratory flow over first 2 weeks

Interventions

MK0476, montelukast sodium / Duration of Treatment: 4 WeeksDRUG
Comparator: ketotifen / Duration of Treatment: 4 WeeksDRUG

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Intermittent asthma, mild persistent asthma, moderate persistent asthma, or severe persistent asthma patients with 2 or more mild or moderate attacks at baseline

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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

    RESULT

MeSH Terms

Conditions

Asthma

Interventions

montelukastDuration of Therapy

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2007

First Posted

March 12, 2007

Study Start

September 25, 2003

Primary Completion

June 16, 2004

Study Completion

June 16, 2004

Last Updated

August 15, 2024

Record last verified: 2022-02