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A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)

Primary Purpose

Seasonal Allergic Rhinitis

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 Seasonal Allergic Rhinitis

Eligibility Criteria

2 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient has a history of allergic rhinitis symptoms which flare up during the study season
  • Patient is a non-smoker
  • Patient is in otherwise good health
  • Patient is able to chew a tablet

Exclusion Criteria:

  • Patient is hospitalized
  • Patient is pregnant or nursing mother, or <8 weeks post partum
  • Patient and/or parent intend to move or vacation away from home during the trial
  • Patient has had a major surgical procedure within 4 weeks of the prestudy visit
  • Patient has been treated in an emergency room or hospitalized for asthma within 3 months prior to study
  • Patient has an upper respiratory, eye, or sinus infection, or a history of any of these within 3 weeks prior to study
  • Patient has a recent history of a psychiatric disorder or attention deficit hyperactivity disorder

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 (CAEs)
    A clinical 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 Serious CAEs
    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 Drug-related CAEs
    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 Who Were Discontinued Due to CAEs
    Number of Patients With Laboratory Adverse Experiences (LAEs)
    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 Serious LAEs
    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 Drug-related LAEs
    Number of Patients Who Were Discontinued Due to LAEs

    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
    NCT00968149
    Brief Title
    A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)
    Official Title
    A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Age 2 Through 14 Years With Seasonal Allergic Rhinitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2001 (undefined)
    Primary Completion Date
    June 2001 (Actual)
    Study Completion Date
    July 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
    This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Seasonal Allergic Rhinitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    413 (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 montelukast chewable tablet daily at bed time for 2 weeks, 4 mg for patients aged 2-5 years and 5 mg for patients 6-14 years
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    one placebo chewable tablet daily at bed time for 2 weeks
    Primary Outcome Measure Information:
    Title
    Number of Patients With Clinical Adverse Experiences (CAEs)
    Description
    A clinical 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
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Number of Patients With Serious CAEs
    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
    2 weeks
    Title
    Number of Patients With Drug-related CAEs
    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
    2 weeks
    Title
    Number of Patients Who Were Discontinued Due to CAEs
    Time Frame
    2 weeks
    Title
    Number of Patients With Laboratory Adverse Experiences (LAEs)
    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
    2 weeks
    Title
    Number of Patients With Serious LAEs
    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
    2 weeks
    Title
    Number of Patients With Drug-related LAEs
    Time Frame
    2 weeks
    Title
    Number of Patients Who Were Discontinued Due to LAEs
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient has a history of allergic rhinitis symptoms which flare up during the study season Patient is a non-smoker Patient is in otherwise good health Patient is able to chew a tablet Exclusion Criteria: Patient is hospitalized Patient is pregnant or nursing mother, or <8 weeks post partum Patient and/or parent intend to move or vacation away from home during the trial Patient has had a major surgical procedure within 4 weeks of the prestudy visit Patient has been treated in an emergency room or hospitalized for asthma within 3 months prior to study Patient has an upper respiratory, eye, or sinus infection, or a history of any of these within 3 weeks prior to study Patient has a recent history of a psychiatric disorder or attention deficit hyperactivity disorder
    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
    19449366
    Citation
    Bisgaard H, Skoner D, Boza ML, Tozzi CA, Newcomb K, Reiss TF, Knorr B, Noonan G. Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions. Pediatr Pulmonol. 2009 Jun;44(6):568-79. doi: 10.1002/ppul.21018.
    Results Reference
    result

    Learn more about this trial

    A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)

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