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Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED)

Primary Purpose

Rhinitis, Allergic, Seasonal

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
loratadine; montelukast
Sponsored by
Organon and Co
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria: Aged 15 years or older, of either sex and of any race. At least a 2-year documented history of SAR with symptoms during the study season. A positive skin-prick test response to seasonal Clinically symptomatic at Screening and at the Baseline Visits General good health. Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluations. Willingness (subjects and/or a parent/guardian) to give written informed consent and ability to adhere to dosing and visit schedules and meet study requirements. Negative pregnancy test Exclusion Criteria: A history of anaphylaxis and/or other severe local reaction(s) to skin testing. Asthma requiring chronic use of inhaled or systemic corticosteroids. Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip. Rhinitis medicamentosa. A history of allergies to more than two classes of medications or allergy to or intolerance of antihistamines, montelukast, or pseudoephedrine. An upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14 day washout prior to the Screening Visit, or a viral upper respiratory infection within 7 days before the Screening Visit. Nasal structural abnormalities, including large nasal polyps and marked septal deviations, that significantly interfere with nasal air flow. Dependence (in the opinion of the investigator) on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids. Narrow-angle glaucoma, increased intraocular pressure, urinary retention, hypertension, severe coronary artery disease, ischemic heart disease, diabetes mellitus, hyperthyroidism, renal impairment, or prostatic hypertrophy, and those receiving monamine oxidase (MAO) inhibitor therapy. Use of any drug in an investigational protocol in the 30 days before the Screening Visit. Current immunotherapy (desensitization therapy), unless on a regular maintenance schedule prior to the Screening Visit, which should be maintained for the remainder of the study. No desensitization treatment within 24 hours before any visit. Requirement for chronic use of tricyclic antidepressants. Pregnancy or lactation. Family member of the investigation study staff. Current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject's participation in the study. Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism, or excretion of the study drug or interfere with the subject's ability to complete or reliably complete the diary card. Significant medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment. Compromised ability to provide informed consent.. A history of noncompliance with medications or treatment protocols.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 28, 2006
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
    Collaborators
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00319995
    Brief Title
    Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED)
    Official Title
    Efficacy and Safety of Combination Loratadine/Montelukast QD vs Pseudoephedrine and Placebo in the Treatment of Subjects With Seasonal Allergic Rhinitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2006 (Actual)
    Primary Completion Date
    June 1, 2006 (Actual)
    Study Completion Date
    June 28, 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co
    Collaborators
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    This is a Phase 3, randomized, parallel-group, multicenter, double-dummy, double-blind study with a screening period. Subjects will receive one of the following three treatment groups for 15 days: loratadine 10 mg/montelukast 10 mg combination, pseudoephedrine 240 mg, or placebo. The primary objective of this study is to assess the efficacy of the combination of loratadine/montelukast, a once-daily tablet containing 10 mg loratadine and 10 mg montelukast, compared with placebo in subjects with seasonal allergic rhinitis (SAR) in relieving the symptom of nasal congestion. The safety profile of combined loratadine/montelukast relative to placebo and pseudoephedrine will also be evaluated.

    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
    1095 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    loratadine; montelukast

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 15 years or older, of either sex and of any race. At least a 2-year documented history of SAR with symptoms during the study season. A positive skin-prick test response to seasonal Clinically symptomatic at Screening and at the Baseline Visits General good health. Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluations. Willingness (subjects and/or a parent/guardian) to give written informed consent and ability to adhere to dosing and visit schedules and meet study requirements. Negative pregnancy test Exclusion Criteria: A history of anaphylaxis and/or other severe local reaction(s) to skin testing. Asthma requiring chronic use of inhaled or systemic corticosteroids. Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip. Rhinitis medicamentosa. A history of allergies to more than two classes of medications or allergy to or intolerance of antihistamines, montelukast, or pseudoephedrine. An upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14 day washout prior to the Screening Visit, or a viral upper respiratory infection within 7 days before the Screening Visit. Nasal structural abnormalities, including large nasal polyps and marked septal deviations, that significantly interfere with nasal air flow. Dependence (in the opinion of the investigator) on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids. Narrow-angle glaucoma, increased intraocular pressure, urinary retention, hypertension, severe coronary artery disease, ischemic heart disease, diabetes mellitus, hyperthyroidism, renal impairment, or prostatic hypertrophy, and those receiving monamine oxidase (MAO) inhibitor therapy. Use of any drug in an investigational protocol in the 30 days before the Screening Visit. Current immunotherapy (desensitization therapy), unless on a regular maintenance schedule prior to the Screening Visit, which should be maintained for the remainder of the study. No desensitization treatment within 24 hours before any visit. Requirement for chronic use of tricyclic antidepressants. Pregnancy or lactation. Family member of the investigation study staff. Current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject's participation in the study. Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism, or excretion of the study drug or interfere with the subject's ability to complete or reliably complete the diary card. Significant medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment. Compromised ability to provide informed consent.. A history of noncompliance with medications or treatment protocols.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19549427
    Citation
    Prenner B, Anolik R, Danzig M, Yao R. Efficacy and safety of fixed-dose loratadine/montelukast in seasonal allergic rhinitis: effects on nasal congestion. Allergy Asthma Proc. 2009 May-Jun;30(3):263-9. doi: 10.2500/aap.2009.30.3228.
    Results Reference
    derived
    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

    Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED)

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