A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

Perennial Allergic Rhinitis Clinical Trial

Official title:

A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (A Randomized, Double-blind, Placebo-controlled Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425632
• Other study ID #: TAU-284-17
• Status: Completed
• Phase: Phase 3
• First received: August 28, 2011
• Last updated: November 10, 2015
• Start date: August 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2015
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• TAU-284
TAU-284 Low
• TAU-284
TAU-284 High
• Placebo
Placebo

Locations

Country	Name	City	State
Japan	Reserch site	Chubu
Japan	Reserch site	Hokuriku
Japan	Reserch site	Kanto
Japan	Reserch site	Kinki
Japan	Reserch site	Kyusyu

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)	Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .	Baseline and Week 2	No
Secondary	Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]		Week 2	No
Secondary	Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)		Week 2	No
Secondary	Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)		Week 2	No
Secondary	Change From Baseline in Severity Score		Week 2	No
Secondary	Adverse Events and Adverse Drug Reactions		Week 2	Yes
Secondary	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)		Week 2	No