Placebo-controlled Trial With Nasonex for Nasal Obstruction Secondary to Adenoids Hypertrophy in Children (P04367)(TERMINATED)
|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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|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.
|Placebo Comparator: Placebo Nasal Spray||
Drug: placebo nasal spray
One spray in each nostril once daily for 3 months.
- 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. ]
- 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. ]