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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
127
100 mcg nasal spray
One spray of placebo nasal spray in each nostril once daily for 4 months.
Change From Baseline 24-hour Urinary Free Cortisol Level
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.
Time frame: Baseline to Endpoint
Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine
The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine).
Time frame: Baseline to Endpoint
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