Clinical Trial: Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years old. Safety will be the primary focus of this study.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Change From Baseline 24-hour Urinary Free Cortisol Level [ Time Frame: Baseline to Endpoint ]

The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to <18 years of age. Primary safety was to be assessed by determining the subject's 24-hour urinary free cortisol level.


Original Primary Outcome:

Current Secondary Outcome: Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine [ Time Frame: Baseline to Endpoint ]

The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine).


Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: September 18, 2006
Date Started: July 2006
Date Completion:
Last Updated: March 13, 2017
Last Verified: March 2017