The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis and to investigate safety of TAU-284.
This is a randomized, double-blind, placebo-controlled, 2-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (20 mg/day) or placebo to pediatric patients with perennial allergic rhinitis, with "the change from baseline in total nasal symptom score (total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\])" as the primary endpoint; and to investigate safety of TAU-284.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
473
Two TAU-284 5mg tablets will be taken orally twice a day
Two Placebo tablets will be taken orally twice a day
Reserch site
Fukuoka, Japan
Reserch site
Toyama, Japan
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptoms) to 4 (very severe).
Time frame: Baseline and Week 2
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
Time frame: baseline, Week1 and Week 2
Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
Time frame: baseline, Week1 and Week 2
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Time frame: baseline, Week1 and Week 2
Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis
Time frame: Randomization, Week1 and Week 2
Adverse Events and Adverse Drug Reactions
Time frame: Week 2
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