NCT00553891

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

Double Blind, Placebo Controlled Trial, Evaluating the Role of Nasonex® in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	mometasone furoate nasal spray	One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months.
DRUG	placebo nasal spray	One spray in each nostril once daily for 3 months.

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2007-11-06
• Last updated: 2022-02-18