This study is to evaluate the effectiveness of a new drug on congestion in subjects with seasonal allergic rhinitis. This effect will be compared to placebo and to the decongestant, pseudoephedrine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
265
(4X50mg Capsules)
Encapsulated pseudoephedrine (2X30 mg immediate release tablets)
Placebo
Average change from baseline in nasal congestion scores over the first 4-hour observation period.
Time frame: Over the first 4-hour observation period.
Average change from baseline in nasal congestion at each evaluation time point.
Time frame: Over 12 hours.
Average change from baseline in total symptoms, total symptoms minus congestion, total nasal symptoms, total nasal symptoms minus congestion, total non-nasal symptoms, and individual symptoms scores.
Time frame: Over the first 4 hour and 12-hour study periods.
Onset of action: defined as the first time point at which a sustained, statistically significant (P<=0.05) reduction relative to placebo in an efficacy variable (eg, nasal congestion) up to a pre-specified time point.
Time frame: Over the first 4-hours and 12-hour study periods.
Average change from baseline in PNIF over the first 4-hour and 12-hour study periods and at each time point.
Time frame: Over the first 4-hour and 12-hour study periods.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.