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

This study has been terminated.
(No enrollment because of war in the study country.)
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00553891
First received: November 5, 2007
Last updated: March 31, 2010
Last verified: March 2010
History of Changes
  Purpose

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 Intervention Phase
Nasal Obstruction
Adenoids Hypertrophy
Adenoidectomy
 Drug: mometasone furoate nasal spray
Drug: placebo nasal spray
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

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. [ Time Frame: The total duration of therapy is 3 months the follow up period is for 12 months. ] [ Designated as safety issue: Yes ]

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. [ Time Frame: The total duration of therapy is 3 months the follow up period is for 12 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 285
Study Start Date: May 2006
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00553891     History of Changes
Other Study ID Numbers: P04367
Study First Received: November 5, 2007
Last Updated: March 31, 2010
Health Authority: Lebanon: Institutional Review Board

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-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013