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Nasonex for Nasal Obstruction due to Adenoids Hypertrophy in Children
NCT00553891Phase 4
Key facts
- Status
- Withdrawn
- Start
- May 2006
- Primary completion
- Oct 2009
- Sponsor
- Organon & Co.
- Modality
- Small Molecules
- Conditions
- adenoid hypertrophy
01
Overview
Phase 4, randomised, double-blind trial in adenoid hypertrophy comparing Nasonex Nasal Spray with Placebo Nasal Spray (2 arms). Primary endpoint: Need for adenoidectomy within one year of the treatment regimen at 1 year. Planned start May 2006; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Nasonex Nasal Spray
Mometasone furoate nasal spray 100 mcg daily
Placebo Nasal Spray
Placebo nasal spray once daily
03
Who it enrols
Children aged 2-11 with nasal obstruction for at least 3 months and evidence of adenoids hypertrophy causing >50% obstruction. Excludes patients with <50% obstruction, recurrent epistaxis, immunodeficiency, severe septal deviation, nasal polyps, chronic otitis media, cystic fibrosis, or active infection.
04
Endpoints
Primary
Need for adenoidectomy within one year of the treatment regimen
Secondary
Resolution of nasal obstruction symptoms secondary to enlarged adenoids
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