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Placebo-controlled Trial With Nasonex for Nasal Obstruction Secondary to Adenoids Hypertrophy in Children (P04367)(TERMINATED)

Primary Purpose

Nasal Obstruction, Adenoids Hypertrophy, Adenoidectomy

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
mometasone furoate nasal spray
placebo nasal spray
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Obstruction

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Should be between 2 and 11 years.
  • Should have nasal obstruction for at least 3 months.
  • Should have evidence of adenoids hypertrophy by nasopharyngoscopy, which cause >50% obstruction of the posterior choanae.
  • May have concomitant allergic rhinitis, by history, & and specific blood studies; however, the symptoms should be under control during the study period.

Exclusion Criteria:

  • Patients with less than 50% obstruction of the post choanae.
  • Patients with history of recurrent epistaxis or immunodeficiency.
  • Patients with severe septal deviation.
  • Patients with unilateral or bilateral choanal atresia, large nasal polyps or any nasal mass.
  • Known allergy to the drug.
  • Presence of chronic otitis media defined as: otorreha + perforation (concomitant otitis media with effusion, or recurrent otitis media are not excluded).
  • Cystic fibrosis & other causes responsible for nasal obstruction.
  • Infection (ie; sinusitis).
  • History of recent surgery or trauma to nose, unless all wounds have healed.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Nasonex Nasal Spray

    Placebo Nasal Spray

    Arm Description

    Outcomes

    Primary Outcome Measures

    To document the long-term effect of treatment with Nasonex in moderate to severe adenoids hypertrophy (which cause >50% obstruction of the posterior choanae). as reflected by the need for adenoidectomy within one year of the treatment regimen.

    Secondary Outcome Measures

    To identify the characteristics of subjects who will show complete or significant resolution of the nasal obstruction symptoms secondary to enlarged adenoids, upon using Nasonex.

    Full Information

    First Posted
    November 5, 2007
    Last Updated
    February 11, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00553891
    Brief Title
    Placebo-controlled Trial With Nasonex for Nasal Obstruction Secondary to Adenoids Hypertrophy in Children (P04367)(TERMINATED)
    Official Title
    Double Blind, Placebo Controlled Trial, Evaluating the Role of Nasonex® in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No enrollment because of war in the study country.
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    October 2009 (Actual)
    Study Completion Date
    October 2009 (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 is a randomized, double-blind, placebo-controlled study to document the long-term effect of treatment with mometasone furoate nasal spray in moderate to severe adenoids hypertrophy as reflected by the need for removal of the adenoids within one year of the treatment regimen. Subjects will be assigned treated with either mometasone furoate nasal spray or placebo for 3 months. Subjects will be followed for an addition 12 months. Serious AEs will be followed starting first dose-till 30 days after study treatment period completion. This study was terminated - Please see "P04367 - Lebanon"

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasal Obstruction, Adenoids Hypertrophy, Adenoidectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nasonex Nasal Spray
    Arm Type
    Experimental
    Arm Title
    Placebo Nasal Spray
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    mometasone furoate nasal spray
    Other Intervention Name(s)
    SCH 32088, Nasonex
    Intervention Description
    One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo nasal spray
    Intervention Description
    One spray in each nostril once daily for 3 months.
    Primary Outcome Measure Information:
    Title
    To document the long-term effect of treatment with Nasonex in moderate to severe adenoids hypertrophy (which cause >50% obstruction of the posterior choanae). as reflected by the need for adenoidectomy within one year of the treatment regimen.
    Time Frame
    The total duration of therapy is 3 months the follow up period is for 12 months.
    Secondary Outcome Measure Information:
    Title
    To identify the characteristics of subjects who will show complete or significant resolution of the nasal obstruction symptoms secondary to enlarged adenoids, upon using Nasonex.
    Time Frame
    The total duration of therapy is 3 months the follow up period is for 12 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Should be between 2 and 11 years. Should have nasal obstruction for at least 3 months. Should have evidence of adenoids hypertrophy by nasopharyngoscopy, which cause >50% obstruction of the posterior choanae. May have concomitant allergic rhinitis, by history, & and specific blood studies; however, the symptoms should be under control during the study period. Exclusion Criteria: Patients with less than 50% obstruction of the post choanae. Patients with history of recurrent epistaxis or immunodeficiency. Patients with severe septal deviation. Patients with unilateral or bilateral choanal atresia, large nasal polyps or any nasal mass. Known allergy to the drug. Presence of chronic otitis media defined as: otorreha + perforation (concomitant otitis media with effusion, or recurrent otitis media are not excluded). Cystic fibrosis & other causes responsible for nasal obstruction. Infection (ie; sinusitis). History of recent surgery or trauma to nose, unless all wounds have healed.

    12. IPD Sharing Statement

    Learn more about this trial

    Placebo-controlled Trial With Nasonex for Nasal Obstruction Secondary to Adenoids Hypertrophy in Children (P04367)(TERMINATED)

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