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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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"

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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. ]

Original Secondary Outcome: Same as current

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: November 5, 2007
Date Started: May 2006
Date Completion:
Last Updated: August 12, 2015
Last Verified: August 2015