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

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ClinicalTrials.gov Identifier: NCT01900054
Recruitment Status : Completed
First Posted : July 16, 2013
Results First Posted : December 14, 2015
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Perennial Allergic Rhinitis
Intervention Drug: Bepotastine besilate
Enrollment 58

Recruitment Details  
Pre-assignment Details  
Arm/Group Title TAU-284
Hide Arm/Group Description TAU-284 10mg twice daily for 12 weeks
Period Title: Overall Study
Started 58
Completed 56
Not Completed 2
Reason Not Completed
Physician Decision             1
Withdrawal by Subject             1
Arm/Group Title TAU-284
Hide Arm/Group Description TAU-284 10mg twice daily for 12 weeks
Overall Number of Baseline Participants 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants
11.2  (2.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
Female
25
  43.1%
Male
33
  56.9%
1.Primary Outcome
Title Number of Patients With Adverse Events and Adverse Drug Reactions
Hide Description [Not Specified]
Time Frame Up to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TAU-284
Hide Arm/Group Description:
TAU-284 10mg twice daily for 12 weeks
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: participants
Adverse events 37
Adverse drug reactions 2
2.Secondary Outcome
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.
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TAU-284
Hide Arm/Group Description:
TAU-284 10mg twice daily for 12 weeks
Overall Number of Participants Analyzed 58
Median (Standard Deviation)
Unit of Measure: units on a scale
Week 2 -0.943  (1.549)
Week 4 -1.388  (1.465)
Week 6 -1.321  (1.844)
Week 8 -1.433  (1.880)
Week 10 -1.460  (1.777)
Week 12 -1.451  (1.707)
final evaluation point -1.440  (1.678)
3.Secondary Outcome
Title Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
Hide Description [Not Specified]
Time Frame baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Hide Description [Not Specified]
Time Frame Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis
Hide Description [Not Specified]
Time Frame baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Influence of Activities in Daily Life(Study, Outing, Sleeping)
Hide Description [Not Specified]
Time Frame Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)
Hide Description [Not Specified]
Time Frame Week 12 or suspension
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TAU-284
Hide Arm/Group Description TAU-284 10mg twice daily for 12 weeks
All-Cause Mortality
TAU-284
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TAU-284
Affected / at Risk (%)
Total   0/58 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
TAU-284
Affected / at Risk (%)
Total   31/58 (53.45%) 
Infections and infestations   
Nasopharyngitis  19/58 (32.76%) 
Otitis externa  3/58 (5.17%) 
Pharyngitis  3/58 (5.17%) 
Investigations   
Liver function test abnormal  2/58 (3.45%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract inflammation  5/58 (8.62%) 
Epistaxis  2/58 (3.45%) 
Skin and subcutaneous tissue disorders   
Eczema  2/58 (3.45%) 
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01900054     History of Changes
Other Study ID Numbers: TAU-284-18
First Submitted: July 3, 2013
First Posted: July 16, 2013
Results First Submitted: September 17, 2015
Results First Posted: December 14, 2015
Last Update Posted: April 8, 2016