NCT01135134

Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)

Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No.P06332)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 5 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate (MF) in pediatric subjects with perennial allergic rhinitis. The subjects 5 to 15 years of age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days at minimum and eligibility for inclusion in this study will be assessed. Following the observation period, eligible subjects will be randomized to MF or MF placebo for a 2-week double-blind treatment. At each clinic visit (at the start of treatment and after 1 and 2 weeks of treatment or at discontinuation), nasal symptom scores, nasal findings, and adverse events (AEs), will be evaluated. A 30-day follow-up visit will take place after the completion (or discontinuation) of the 2-week treatment period, to confirm presence or absence of serious adverse events (SAEs) and trial procedure-related AEs.

Conditions

• Rhinitis, Allergic, Perennial

Interventions

Type	Name	Description
DRUG	Mometasone furoate	The study drug is MFNS (50 μg spray device) and the dose will be: * 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks * 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks
DRUG	Placebo	MF Placebo nasal spray and administration will be as follows: * 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks * 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-06-02
• Last updated: 2024-05-28
• Results posted: 2011-11-03