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An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

Primary Purpose

Rhinitis, Allergic, Seasonal

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
montelukast sodium
Comparator: pranlukast
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Seasonal

Eligibility Criteria

15 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress) Exclusion Criteria: Patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histamine drugs (within 2 weeks) before the start of the observation period

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    montelukast sodium 5 mg, QD 2-weeks

    montelukast sodium 10 mg QD 2-weeks

    Pranlukast 225 mg BID 2-weeks

    Outcomes

    Primary Outcome Measures

    Composite Nasal Symptom Score

    Secondary Outcome Measures

    Daytime nasal symptom score, Nighttime nasal symptom score

    Full Information

    First Posted
    August 4, 2005
    Last Updated
    January 31, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00127647
    Brief Title
    An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)
    Official Title
    MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    April 2005 (Actual)
    Study Completion Date
    April 2005 (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 trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1375 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    montelukast sodium 5 mg, QD 2-weeks
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    montelukast sodium 10 mg QD 2-weeks
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    Pranlukast 225 mg BID 2-weeks
    Intervention Type
    Drug
    Intervention Name(s)
    montelukast sodium
    Other Intervention Name(s)
    MK0476, Singulair
    Intervention Description
    montelukast sodium; 5 mg, 10 mg QD 2-weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: pranlukast
    Intervention Description
    Pranlukast 225 mg BID 2-weeks.
    Primary Outcome Measure Information:
    Title
    Composite Nasal Symptom Score
    Secondary Outcome Measure Information:
    Title
    Daytime nasal symptom score, Nighttime nasal symptom score

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress) Exclusion Criteria: Patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histamine drugs (within 2 weeks) before the start of the observation period
    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
    18946234
    Citation
    Okubo K, Baba K. A double-blind non-inferiority clinical study of montelukast, a cysteinyl leukotriene receptor 1 antagonist, compared with pranlukast in patients with seasonal allergic rhinitis. Allergol Int. 2008 Dec;57(4):383-90. doi: 10.2332/allergolint.O-08-533. Epub 2008 Nov 1.
    Results Reference
    result
    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

    An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

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