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A Study in Subjects With Perennial Allergic Rhinitis

Primary Purpose

Perennial Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
INS37217 Nasal Spray
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis

Eligibility Criteria

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Inclusion Criteria: Have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing. Have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies. Have not started or had a change in immunotherapy regimen. Exclusion Criteria: Have a physical obstruction in the nose. Will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial. Have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy. Have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms. Have asthma of sufficient severity to require use of excluded medications. Have taken any medications excluded as listed in the protocol. Have a clinically significant acute or chronic disease or clinically significant laboratory abnormality. Are a current smoker, recent smoker or past smoker as defined in the protocol.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    total nasal symptom score

    Secondary Outcome Measures

    average total nasal symptom scores over various timepoints average individual symptom scores
    global assessment of perennial allergic rhinitis symptoms
    instantaneous assessment of symptoms
    change from baseline in quality of life assessments
    physical and anterior nasal exams
    laboratory tests
    ECG
    vital signs
    adverse events

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    January 22, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00210015
    Brief Title
    A Study in Subjects With Perennial Allergic Rhinitis
    Official Title
    A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of INS37217 Nasal Spray Versus Placebo in Subjects With Perennial Allergic Rhinitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2002 (undefined)
    Primary Completion Date
    April 2003 (Actual)
    Study Completion Date
    April 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study was to determine the efficacy and safety of the study drug compared to placebo for the treatment of subjects with perennial allergic rhinitis.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    630 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    INS37217 Nasal Spray
    Primary Outcome Measure Information:
    Title
    total nasal symptom score
    Secondary Outcome Measure Information:
    Title
    average total nasal symptom scores over various timepoints average individual symptom scores
    Title
    global assessment of perennial allergic rhinitis symptoms
    Title
    instantaneous assessment of symptoms
    Title
    change from baseline in quality of life assessments
    Title
    physical and anterior nasal exams
    Title
    laboratory tests
    Title
    ECG
    Title
    vital signs
    Title
    adverse events

    10. Eligibility

    Eligibility Criteria
    Inclusion Criteria: Have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing. Have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies. Have not started or had a change in immunotherapy regimen. Exclusion Criteria: Have a physical obstruction in the nose. Will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial. Have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy. Have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms. Have asthma of sufficient severity to require use of excluded medications. Have taken any medications excluded as listed in the protocol. Have a clinically significant acute or chronic disease or clinically significant laboratory abnormality. Are a current smoker, recent smoker or past smoker as defined in the protocol.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amy Schaberg, B.S.N.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study in Subjects With Perennial Allergic Rhinitis

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