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Pseudoephedrine for Rhinitis and Sleep
NCT00704496Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2007
- Primary completion
- Sep 2009
- Countries
- 1
- Sponsor
- Penn State Health Milton S. Hershey Medical Center
- Modality
- Small Molecules
- Drugs
- pseudoephedrine
- Conditions
- perennial allergic rhinitis (PAR)
01
Overview
Phase 3, randomised, double-blind trial in perennial allergic rhinitis (PAR) comparing Pseudoephedrine with Placebo (2 arms). Primary endpoint: Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo at 3 years. Started Jun 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Pseudoephedrine
Pseudoephedrine 240 mg PO per day
Placebo
Placebo comparator
03
Who it enrols
Adults 18-65 with perennial allergic rhinitis, daytime sleepiness, and poor sleep. Excludes sleep apnea, hypertension, diabetes, and other atopic diseases.
04
Endpoints
Primary
Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo
Secondary
Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo
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