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

March 10, 2016 updated by: Mitsubishi Tanabe Pharma Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kanagawa, Japan
        • Reserch site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAU-284
Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).
Drug: Bepotastine besilate
Two TAU-284 5mg tablets will be taken orally twice a day
Other Names:
  • TALION 5mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients With Adverse Events and Adverse Drug Reactions
Time Frame: Up to Week 12
Up to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）
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).
Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）
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
baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Time Frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis
Time Frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Influence of Activities in Daily Life(Study, Outing, Sleeping)
Time Frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)
Time Frame: Week 12 or suspension
Week 12 or suspension

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

July 3, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (Estimate)

July 16, 2013

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAU-284-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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