The primary objective of the study was to examine the efficacy and safety of S-555739/cetirizine HCl compared with the individual components and placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
779
Change in average morning/evening (AM/PM) reflective Total Nasal Symptom Score (rTNSS)
Time frame: Change from baseline through the 2-week treatment period (Day 2 through Day 15)
Incidence of adverse events (AEs)
Time frame: From Screening period to Week 6 (Follow-up)
Change in average AM/PM instantaneous Total Nasal Symptom Score (iTNSS)
Time frame: Change from baseline through the 2-week treatment period (Day 2 through Day 15)
Change in average AM/PM Total Ocular Symptom Score
Time frame: Change from baseline through the 2-week treatment period (Day 2 through Day 15)
Assessment of Quality of Life
Time frame: Change from Week 3 to Week 5
Assessment of vital signs
Time frame: At Week 1 (Screening), Week 2, Week 3, Week 4, and Week 5
Assessment of clinical laboratory parameters
Time frame: At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up)
Assessment of electrocardiogram (ECG) findings
Time frame: At Week 1 (Screening) and Week 5
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