Primary Objective: To assess the safety of twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10) combination tablet in patients with allergic rhinitis. Secondary Objective: To evaluate the effectiveness of a twice-daily FEX60/PE10 combination tablet on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), and daily activity impairment.
It will be 22 days at minimum and up to 32 days depending on screening, treatment, and post-treatment observation allowances.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Pharmaceutical form:tablet Route of administration: oral
Sanofi Administrative Office
Tokyo, Japan
Number of adverse events (Solicited AE reporting)
Time frame: From intake of FEX60/PE10 up to approximately 2 weeks
Changes from baseline in the nasal congestion score based on the patient's symptom diary
Time frame: After 2 weeks treatment
Change from baseline in the total score of 3 nasal symptoms (sneezing, rhinorrhea, and nasal congestion)
Time frame: After 2 weeks treatment
Change in the total score of 3 nasal symptoms on a daily basis
Time frame: After 2 weeks treatment
Change in the total score of 3 nasal symptoms during daytime
Time frame: After 2 weeks treatment
Change in the total score of 3 nasal symptoms during night-time
Time frame: After 2 weeks treatment
Change in the daily activity impairment score
Time frame: After 2 weeks treatment
Change in the daily activity impairment score on a daily basis
Time frame: After 2 weeks treatment
Change in the daily activity impairment score during daytime
Time frame: After 2 weeks treatment
Change in the daily activity impairment score during night-time
Time frame: After 2 weeks treatment
Change in nasal findings from baseline: color of inferior turbinate mucosa
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Time frame: After 2 weeks treatment
Change in nasal findings from baseline: congestion of inferior turbinate mucosa
Time frame: After 2 weeks treatment
Change in nasal findings from baseline: consistency of discharge
Time frame: After 2 weeks treatment
Assessment of patient's impression after treatment based on patient's symptom diary
Time frame: After 2 weeks treatment