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

Organon

Status and phase

Withdrawn

Phase 4

Conditions

Nasal Obstruction

Adenoids Hypertrophy

Adenoidectomy

Treatments

Drug: placebo nasal spray

Drug: mometasone furoate nasal spray

Study type

Interventional

Funder types

Industry

Identifiers

NCT00553891

P04367

Details and patient eligibility

About

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"

Sex

All

Ages

2 to 11 years old

Volunteers

No 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.