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

NCT ID: NCT00553891

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-10-31

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"

Conditions

Nasal Obstruction; Adenoids Hypertrophy; Adenoidectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nasonex Nasal Spray

Group Type: EXPERIMENTAL

mometasone furoate nasal spray

Intervention Type: DRUG

One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months.

Placebo Nasal Spray

Group Type: PLACEBO_COMPARATOR

placebo nasal spray

Intervention Type: DRUG

One spray in each nostril once daily for 3 months.

Interventions

mometasone furoate nasal spray

One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months.

Intervention Type: DRUG

placebo nasal spray

One spray in each nostril once daily for 3 months.

Intervention Type: DRUG

Other Intervention Names

SCH 32088; Nasonex

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04367

Identifier Type: -

Identifier Source: org_study_id