NCT01165424

A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)

A Study of Long-term (12-24 Weeks) Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No. P06333)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 3 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal representatives) provided consent to continue treatment beyond 12 weeks will receive treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse events and trial procedure-related AEs will be reviewed 30 days after the end of the follow-up.

Conditions

• Rhinitis, Allergic, Perennial

Interventions

Type	Name	Description
DRUG	mometasone furoate	MFNS 50 μg spray device * 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning. * 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning.

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-07-19
• Last updated: 2024-05-24
• Results posted: 2012-01-23