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

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ClinicalTrials.gov Identifier: NCT00553891
Recruitment Status : Terminated (No enrollment because of war in the study country.)
First Posted : November 6, 2007
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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"


Condition or disease Intervention/treatment Phase
Nasal Obstruction Adenoids Hypertrophy Adenoidectomy Drug: mometasone furoate nasal spray Drug: placebo nasal spray Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nasonex Nasal Spray Drug: mometasone furoate nasal spray
One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months.
Other Names:
  • SCH 32088
  • Nasonex
Placebo Comparator: Placebo Nasal Spray Drug: placebo nasal spray
One spray in each nostril once daily for 3 months.



Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]


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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00553891     History of Changes
Other Study ID Numbers: P04367
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Hypertrophy
Nasal Obstruction
Pathological Conditions, Anatomical
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents