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MK0476 Study in Adult Patients With Allergic Rhinitis (0476-378)

Primary Purpose

Rhinitis Allergic

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0476, montelukast sodium / Duration of Treatment: 2 Weeks
Comparator: placebo / Duration of Treatment: 2 Weeks
Sponsored by
Organon and Co
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis Allergic

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients with seasonal allergic rhinitis

Exclusion Criteria:

  • Patients who have nasal diseases (e.g., nasal polyp, septonasal arcuation, hypertrophic rhinitis), upper respiratory infection, sinusitis, infectious rhinitis, ocular infection and those disease severe enough to interfere with assessment of effectiveness
  • Patients who have rhinitis medicamentosa, or nonallergic rhinitis (e.g., vasomotor rhinitis, eosinophilia rhinitis)
  • Patient has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The change from baseline in the composite nasal symptoms score (average over the 2-week treatment period) in seasonal allergic rhinitis

    Secondary Outcome Measures

    Full Information

    First Posted
    March 9, 2007
    Last Updated
    January 31, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00446186
    Brief Title
    MK0476 Study in Adult Patients With Allergic Rhinitis (0476-378)
    Official Title
    Mk0476 Phase II Dose Finding Study -Allergic Rhinitis-
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2004 (undefined)
    Primary Completion Date
    March 2004 (Actual)
    Study Completion Date
    March 2004 (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 clinical study evaluates the efficacy and safety of MK0476 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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    945 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0476, montelukast sodium / Duration of Treatment: 2 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo / Duration of Treatment: 2 Weeks
    Primary Outcome Measure Information:
    Title
    The change from baseline in the composite nasal symptoms score (average over the 2-week treatment period) in seasonal allergic rhinitis

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients with seasonal allergic rhinitis Exclusion Criteria: Patients who have nasal diseases (e.g., nasal polyp, septonasal arcuation, hypertrophic rhinitis), upper respiratory infection, sinusitis, infectious rhinitis, ocular infection and those disease severe enough to interfere with assessment of effectiveness Patients who have rhinitis medicamentosa, or nonallergic rhinitis (e.g., vasomotor rhinitis, eosinophilia rhinitis) Patient has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe 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
    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
    PubMed Identifier
    18566548
    Citation
    Okubo K, Baba K. Therapeutic effect of montelukast, a cysteinyl leukotriene receptor 1 antagonist, on Japanese patients with seasonal allergic rhinitis. Allergol Int. 2008 Sep;57(3):247-55. doi: 10.2332/allergolint.O-07-515. Epub 2008 Jul 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

    MK0476 Study in Adult Patients With Allergic Rhinitis (0476-378)

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