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Linear Growth Study (0476-097)(COMPLETED)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0476, montelukast sodium / Duration of Treatment : 56 Weeks
Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks
Sponsored by
Organon and Co
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

6 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria :

  • Boys (aged 6 to 8 years at Visit 1) at Tanner Stage I (prepuberty)
  • Girls (aged 6 to 7 years at Visit 1) at Tanner Stage I (prepuberty
  • With at least a 6-month history of asthma with typical symptoms (including, but not limited to cough, wheeze, and shortness of breath, with periodic episodes requiring treatment with inhaled beta-agonists)

Exclusion Criteria :

  • Patients who used more than 2 courses of inhaled corticosteroids within the 12 months prior to Visit 1

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To establish the difference in the average rate of linear growth over the 56-week double-blind treatment period between the montelukast and placebo groups

    Secondary Outcome Measures

    To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1
    Beta-agonist use
    Oral corticosteroid rescues for asthma
    Discontinuations due to asthma
    Peripheral blood eosinophil count
    Markers of bone turn-over

    Full Information

    First Posted
    November 1, 2006
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00395408
    Brief Title
    Linear Growth Study (0476-097)(COMPLETED)
    Official Title
    A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing the Effect on Linear Growth of Montelukast With Placebo and Inhaled Beclomethasone in Pediatric Patients (Prepubertal, Tanner Stage I) With Mild Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2000 (undefined)
    Primary Completion Date
    December 2003 (Actual)
    Study Completion Date
    December 2003 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthma.

    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 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    360 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0476, montelukast sodium / Duration of Treatment : 56 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks
    Primary Outcome Measure Information:
    Title
    To establish the difference in the average rate of linear growth over the 56-week double-blind treatment period between the montelukast and placebo groups
    Secondary Outcome Measure Information:
    Title
    To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1
    Title
    Beta-agonist use
    Title
    Oral corticosteroid rescues for asthma
    Title
    Discontinuations due to asthma
    Title
    Peripheral blood eosinophil count
    Title
    Markers of bone turn-over

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria : Boys (aged 6 to 8 years at Visit 1) at Tanner Stage I (prepuberty) Girls (aged 6 to 7 years at Visit 1) at Tanner Stage I (prepuberty With at least a 6-month history of asthma with typical symptoms (including, but not limited to cough, wheeze, and shortness of breath, with periodic episodes requiring treatment with inhaled beta-agonists) Exclusion Criteria : Patients who used more than 2 courses of inhaled corticosteroids within the 12 months prior to Visit 1
    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
    16802767
    Citation
    Becker AB, Kuznetsova O, Vermeulen J, Soto-Quiros ME, Young B, Reiss TF, Dass SB, Knorr BA; Pediatric Montelukast Linear Growth Study Group. Linear growth in prepubertal asthmatic children treated with montelukast, beclomethasone, or placebo: a 56-week randomized double-blind study. Ann Allergy Asthma Immunol. 2006 Jun;96(6):800-7. doi: 10.1016/s1081-1206(10)61342-7.
    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

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    Linear Growth Study (0476-097)(COMPLETED)

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