A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (A Randomized, Double-blind, Placebo-controlled Study)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Tanabe Pharma Corporation
- Enrollment
- 473
- Locations
- 2
- Primary Endpoint
- Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 7 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged between 7 and 15 years
- •Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
- •Patients with a mean rhinorrhea score and a mean sneezing score of at least 2 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc.
Exclusion Criteria
- •Patients with vasomotor rhinitis or eosinophilic rhinitis
- •Patients who have concurrent nasal disease that may affect the efficacy of TAU-284
- •Patients with a history of any of the nasal surgical procedures
- •Patients who have a positive result for pollen antigens which are dispersed during the study period
- •Patients who have a positive result for dog dander or cat dander antigen and have a chance to touch dogs or cats.
- •Patients with current or previous history of drug allergy
- •Patients who concurrently have renal function abnormalities that may cause safety problems etc.
Arms & Interventions
TAU-284
Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).
Intervention: Bepotastine besilate (Drug)
Placebo
Two placebo tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
Time Frame: Baseline and Week 2
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).
Secondary Outcomes
- Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)(baseline, Week1 and Week 2)
- Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)(baseline, Week1 and Week 2)
- Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis(Randomization, Week1 and Week 2)
- Adverse Events and Adverse Drug Reactions(Week 2)
- Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion](baseline, Week1 and Week 2)