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Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
montelukast sodium
Comparator: Placebo
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:

  • Patient has history of physician diagnosed asthma
  • Patient is in otherwise good stable health
  • Patient is able to chew a tablet

Exclusion Criteria:

  • Patient is hospitalized
  • Patient and/or parent of guardian intends to move or vacation away from home during the course of the study
  • Patient had any major surgical procedure within 4 weeks before the study
  • Patient had active sinus disease within 3 weeks before the study
  • Patient had required intubation for asthma in the past
  • Patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study
  • Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Montelukast

    Placebo

    Outcomes

    Primary Outcome Measures

    Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

    Secondary Outcome Measures

    Number of Patients With Drug-related CAEs Reported by Patients - Base Study
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
    Number of Patients With Serious CAEs Reported by Patients - Base Study
    Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
    Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study
    Patients who reported serious drug-related CAEs during 12 weeks of treatment
    Number of Patients Who Were Discontinued Due to CAEs - Base Study
    Patients who were discontinued due to CAEs during 12 weeks of treatment
    Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study
    Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment
    Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study
    Patients who were discontinued due to serious CAEs during 12 weeks of treatment
    Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study
    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
    Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
    Number of Patients Who Were Discontinued Due to LAEs - Base Study
    Patients who were discontinued due to LAEs during 12 weeks of treatment
    Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study
    Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment
    Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
    Number of Patients With Drug-related CAEs Reported by Patients - Extension
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
    Number of Patients With Serious CAEs Reported by Patients - Extension
    Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
    Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension
    Patients who reported serious drug-related CAEs up to 2.8 years of treatment
    Number of Patients Who Were Discontinued Due to CAEs - Extension
    Patients who were discontinued due to CAEs up to 2.8 years of treatment
    Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension
    Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment
    Number of Patients Who Were Discontinued Due to Serious CAEs - Extension
    Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment
    Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension
    Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment
    Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension
    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
    Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
    Number of Patients With Serious LAEs - Extension
    Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
    Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension
    Patients who reported serious drug-related LAEs up to 2.8 years of treatment
    Number of Patients Who Were Discontinued Due to LAEs - Extension
    Patients who were discontinued due to LAEs up to 2.8 years of treatment
    Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension
    Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment
    Number of Patients Who Were Discontinued Due to Serious LAEs - Extension
    Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment
    Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension
    Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment

    Full Information

    First Posted
    August 27, 2009
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00968201
    Brief Title
    Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )
    Official Title
    A Multicenter, Double-Blind, Randomized, Parallel-Group Chronic Asthma Study Comparing Montelukast With Placebo in 2- to 5-Year-Old Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1997 (undefined)
    Primary Completion Date
    March 2001 (Actual)
    Study Completion Date
    March 2001 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.

    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
    689 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Montelukast
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    montelukast sodium
    Intervention Description
    one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    one chewable placebo tablet, once daily at bedtime for 12 weeks
    Primary Outcome Measure Information:
    Title
    Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study
    Description
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
    Time Frame
    12 weeks of treatment
    Secondary Outcome Measure Information:
    Title
    Number of Patients With Drug-related CAEs Reported by Patients - Base Study
    Description
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
    Time Frame
    12 weeks of treatment
    Title
    Number of Patients With Serious CAEs Reported by Patients - Base Study
    Description
    Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
    Time Frame
    12 weeks of treatment
    Title
    Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study
    Description
    Patients who reported serious drug-related CAEs during 12 weeks of treatment
    Time Frame
    12 weeks of treatment
    Title
    Number of Patients Who Were Discontinued Due to CAEs - Base Study
    Description
    Patients who were discontinued due to CAEs during 12 weeks of treatment
    Time Frame
    12 weeks of treatment
    Title
    Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study
    Description
    Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment
    Time Frame
    12 weeks of treatment
    Title
    Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study
    Description
    Patients who were discontinued due to serious CAEs during 12 weeks of treatment
    Time Frame
    12 weeks of treatment
    Title
    Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study
    Description
    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
    Time Frame
    12 weeks of treatment
    Title
    Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study
    Description
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
    Time Frame
    12 weeks of treatment
    Title
    Number of Patients Who Were Discontinued Due to LAEs - Base Study
    Description
    Patients who were discontinued due to LAEs during 12 weeks of treatment
    Time Frame
    12 weeks of treatment
    Title
    Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study
    Description
    Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment
    Time Frame
    12 weeks of treatment
    Title
    Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension
    Description
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
    Time Frame
    up to 2.8 years
    Title
    Number of Patients With Drug-related CAEs Reported by Patients - Extension
    Description
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
    Time Frame
    up to 2.8 years
    Title
    Number of Patients With Serious CAEs Reported by Patients - Extension
    Description
    Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
    Time Frame
    up to 2.8 years
    Title
    Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension
    Description
    Patients who reported serious drug-related CAEs up to 2.8 years of treatment
    Time Frame
    up to 2.8 years
    Title
    Number of Patients Who Were Discontinued Due to CAEs - Extension
    Description
    Patients who were discontinued due to CAEs up to 2.8 years of treatment
    Time Frame
    up to 2.8 years
    Title
    Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension
    Description
    Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment
    Time Frame
    up to 2.8 years
    Title
    Number of Patients Who Were Discontinued Due to Serious CAEs - Extension
    Description
    Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment
    Time Frame
    up to 2.8 years
    Title
    Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension
    Description
    Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment
    Time Frame
    up to 2.8 years
    Title
    Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension
    Description
    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
    Time Frame
    up to 2.8 years
    Title
    Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension
    Description
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
    Time Frame
    up to 2.8 years
    Title
    Number of Patients With Serious LAEs - Extension
    Description
    Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
    Time Frame
    up to 2.8 years
    Title
    Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension
    Description
    Patients who reported serious drug-related LAEs up to 2.8 years of treatment
    Time Frame
    up to 2.8 years
    Title
    Number of Patients Who Were Discontinued Due to LAEs - Extension
    Description
    Patients who were discontinued due to LAEs up to 2.8 years of treatment
    Time Frame
    up to 2.8 years
    Title
    Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension
    Description
    Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment
    Time Frame
    up to 2.8 years
    Title
    Number of Patients Who Were Discontinued Due to Serious LAEs - Extension
    Description
    Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment
    Time Frame
    up to 2.8 years
    Title
    Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension
    Description
    Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment
    Time Frame
    up to 2.8 years

    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: Patient has history of physician diagnosed asthma Patient is in otherwise good stable health Patient is able to chew a tablet Exclusion Criteria: Patient is hospitalized Patient and/or parent of guardian intends to move or vacation away from home during the course of the study Patient had any major surgical procedure within 4 weeks before the study Patient had active sinus disease within 3 weeks before the study Patient had required intubation for asthma in the past Patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study
    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
    11533366
    Citation
    Knorr B, Franchi LM, Bisgaard H, Vermeulen JH, LeSouef P, Santanello N, Michele TM, Reiss TF, Nguyen HH, Bratton DL. Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years. Pediatrics. 2001 Sep;108(3):E48. doi: 10.1542/peds.108.3.e48.
    Results Reference
    result

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    Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )

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