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MFNS Efficacy in Seasonal Allergic Rhinitis (EEC Study)
NCT00491504Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2007
- Primary completion
- Jul 2007
- Sponsor
- Organon & Co.
- Modality
- Small Molecules
- Conditions
- seasonal allergic rhinitis (SAR)
01
Overview
Phase 4, randomised, double-blind trial in seasonal allergic rhinitis (SAR) comparing Mometasone Furoate Nasal Spray with Placebo (2 arms). Primary endpoint: Total Nasal Symptom Severity Score. Started Feb 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Mometasone Furoate Nasal Spray
MFNS 200 mcg total dose (2 sprays each nostril)
Placebo
Placebo (2 sprays each nostril)
03
Who it enrols
Adults 18-65 with a 2-year history of SAR and positive skin test to ragweed allergen. Excludes patients with unstable asthma, recent nasal surgery, or those on prohibited medications.
04
Endpoints
Primary
Total Nasal Symptom Severity Score
Secondary
Ocular Symptom Severity Score
Duration of Action
Nasal Blockage Measurement
Subject Opinion of Study Drug
05
Results
Not all primary endpoints met
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