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A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
montelukast
placebo (unspecified)
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or Female between and including the ages of 2 and 5 years
  • Patient was treated with steroids for an asthma episode in the last 3 months
  • Patient was admitted to the hospital or emergency room in the last 3 months
  • Patient is able to chew a tablet

Exclusion Criteria:

  • Patient has been in a research study in the past 4 weeks
  • Patient has visited the emergency room for an asthma episode in the past week
  • Patients has a history of stomach, heart, liver, nerve, kidney or blood disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Drug

    Pbo

    Outcomes

    Primary Outcome Measures

    asthma episodes in 2 - 5 year old children

    Secondary Outcome Measures

    the number of treatments and duration of asthma episodes

    Full Information

    First Posted
    June 17, 2008
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00700661
    Brief Title
    A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)
    Official Title
    A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Study to Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2001 (undefined)
    Primary Completion Date
    December 2002 (Actual)
    Study Completion Date
    December 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    5. Study Description

    Brief Summary
    A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    500 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Drug
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Pbo
    Intervention Type
    Drug
    Intervention Name(s)
    montelukast
    Other Intervention Name(s)
    MK0476, SINGULAIR ®
    Intervention Description
    One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    placebo (unspecified)
    Intervention Description
    Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks
    Primary Outcome Measure Information:
    Title
    asthma episodes in 2 - 5 year old children
    Time Frame
    at 12 months
    Secondary Outcome Measure Information:
    Title
    the number of treatments and duration of asthma episodes
    Time Frame
    at 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or Female between and including the ages of 2 and 5 years Patient was treated with steroids for an asthma episode in the last 3 months Patient was admitted to the hospital or emergency room in the last 3 months Patient is able to chew a tablet Exclusion Criteria: Patient has been in a research study in the past 4 weeks Patient has visited the emergency room for an asthma episode in the past week Patients has a history of stomach, heart, liver, nerve, kidney or blood disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15542792
    Citation
    Bisgaard H, Zielen S, Garcia-Garcia ML, Johnston SL, Gilles L, Menten J, Tozzi CA, Polos P. Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma. Am J Respir Crit Care Med. 2005 Feb 15;171(4):315-22. doi: 10.1164/rccm.200407-894OC. Epub 2004 Nov 12.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)

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