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Mometasone Furoate Nasal Spray in Pediatric Perennial Allergic Rhinitis
NCT01135134Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2010
- Primary completion
- Oct 2010
- Sponsor
- Organon & Co.
- Modality
- Small Molecules
- Conditions
- perennial allergic rhinitis (PAR)
01
Overview
Phase 3, randomised, double-blind trial in perennial allergic rhinitis (PAR) comparing Mometasone furoate nasal spray with Placebo (2 arms). Primary endpoint: Change From Baseline in the Total Nasal Symptom Score at 2 Weeks. Started Jun 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Mometasone furoate nasal spray
MFNS 100 mcg/day (5-11 yrs) or 200 mcg/day (12-15 yrs)
Placebo
Placebo nasal spray
03
Who it enrols
Pediatric subjects (5-15 years) with moderate to severe perennial allergic rhinitis confirmed by allergy to non-seasonal environmental antigens. Excludes subjects with nasal infections, structural nasal defects, or severe systemic diseases.
04
Endpoints
Primary
Change From Baseline in the Total Nasal Symptom Score at 2 Weeks
Secondary
Change From Baseline in the Total Nasal Symptom Score at 1 Week
05
Results
Primary endpoints met
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