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

Primary Purpose

Perennial Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TAU-284
TAU-284
Placebo
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis focused on measuring TAU-284, Bepotastine besilate, Histamine H1 receptor antagonists

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Reserch site
  • Reserch site
  • Reserch site
  • Reserch site
  • Reserch site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

TAU-284 Low

TAU-284 High

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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) .

Secondary Outcome Measures

Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Change From Baseline in Severity Score
Adverse Events and Adverse Drug Reactions
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)

Full Information

First Posted
August 28, 2011
Last Updated
November 10, 2015
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01425632
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis
Keywords
TAU-284, Bepotastine besilate, Histamine H1 receptor antagonists

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAU-284 Low
Arm Type
Experimental
Arm Title
TAU-284 High
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TAU-284
Intervention Description
TAU-284 Low
Intervention Type
Drug
Intervention Name(s)
TAU-284
Intervention Description
TAU-284 High
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)
Description
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) .
Time Frame
Baseline and Week 2
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
Time Frame
Week 2
Title
Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
Time Frame
Week 2
Title
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Time Frame
Week 2
Title
Change From Baseline in Severity Score
Time Frame
Week 2
Title
Adverse Events and Adverse Drug Reactions
Time Frame
Week 2
Title
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)
Time Frame
Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimihiro Okubo, M.D. Ph.D.
Organizational Affiliation
Department of Otorhinolaryngology, Nippon Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Reserch site
City
Chubu
Country
Japan
Facility Name
Reserch site
City
Hokuriku
Country
Japan
Facility Name
Reserch site
City
Kanto
Country
Japan
Facility Name
Reserch site
City
Kinki
Country
Japan
Facility Name
Reserch site
City
Kyusyu
Country
Japan

12. IPD Sharing Statement

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

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