Clinical trial NCT01425632: A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Official title: A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (A Randomized, Double-blind, Placebo-controlled Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Keywords: TAU-284
Bepotastine besilate
Histamine H1 receptor antagonists
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-30
Enrollment: 490
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 the dose response, safety, and plasma concentrations of TAU-284.

Detailed description: This is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (10 mg/day or 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 the dose response, safety, and plasma concentrations of TAU-284.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 7 and 15 years
* Patients with a weight of at least 20 kg
* Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
* Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period

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
* Patients with current or previous history of drug allergy
* Patients who concurrently have renal function abnormalities that may cause safety problems

Primary outcomes:
measure: Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)
timeFrame: Baseline and Week 2
Secondary outcomes:
measure: Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
timeFrame: Week 2
measure: Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
timeFrame: Week 2
measure: Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
timeFrame: Week 2
measure: Change From Baseline in Severity Score
timeFrame: Week 2
measure: Adverse Events and Adverse Drug Reactions
timeFrame: Week 2
measure: Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2)
timeFrame: Week 2
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Reserch site
city: Hokuriku
country: Japan
facility: Reserch site
city: Kanto
country: Japan
facility: Reserch site
city: Kinki
country: Japan
facility: Reserch site
city: Kyusyu
country: Japan
facility: Reserch site
Study officials:
affiliation: Department of Otorhinolaryngology, Nippon Medical School
name: Kimihiro Okubo, M.D. Ph.D.
role: STUDY_DIRECTOR
References: