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A Long-Term 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
Bepotastine besilate
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, children

Eligibility Criteria

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

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 total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 3 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 with current or previous history of drug allergy
  • Patients who concurrently have renal function abnormalities that may cause safety problems etc.

Sites / Locations

  • Reserch site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAU-284

Arm Description

Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).

Outcomes

Primary Outcome Measures

Number of Patients With Adverse Events and Adverse Drug Reactions

Secondary Outcome Measures

Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point.
Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe).
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 for Symptoms of Allergic Rhinitis
Influence of Activities in Daily Life(Study, Outing, Sleeping)
Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)

Full Information

First Posted
July 3, 2013
Last Updated
March 10, 2016
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01900054
Brief Title
A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (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 objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.
Detailed Description
This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

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, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAU-284
Arm Type
Experimental
Arm Description
Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).
Intervention Type
Drug
Intervention Name(s)
Bepotastine besilate
Other Intervention Name(s)
TALION 5mg tablets
Intervention Description
Two TAU-284 5mg tablets will be taken orally twice a day
Primary Outcome Measure Information:
Title
Number of Patients With Adverse Events and Adverse Drug Reactions
Time Frame
Up to Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point.
Description
Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe).
Time Frame
Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）
Title
Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
Time Frame
baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Title
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Time Frame
Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Title
Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis
Time Frame
baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Title
Influence of Activities in Daily Life(Study, Outing, Sleeping)
Time Frame
Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Title
Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)
Time Frame
Week 12 or suspension

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 who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria Patients with a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 3 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 with current or previous history of drug allergy Patients who concurrently have renal function abnormalities that may cause safety problems etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KIMIHIRO OKUBO
Organizational Affiliation
Nippon Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Reserch site
City
Kanagawa
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26364765
Citation
Okubo K, Ichimura M, Koyama T, Susuta Y, Izaki H. Double-blind placebo-controlled study of bepotastine besilate in pediatric patients with perennial allergic rhinitis. Expert Opin Pharmacother. 2015;16(16):2395-408. doi: 10.1517/14656566.2015.1085511. Epub 2015 Sep 12.
Results Reference
result

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

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