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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01425632
First received: August 28, 2011
Last updated: November 10, 2015
Last verified: September 2015
Results First Received: September 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Perennial Allergic Rhinitis
Interventions: Drug: TAU-284
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TAU-284 Low TAU-284 5mg twice daily for 2 weeks
TAU-284 High TAU-284 10mg twice daily for 2 weeks
Placebo TAU-284 placebo twice daily for 2 weeks

Participant Flow:   Overall Study
    TAU-284 Low   TAU-284 High   Placebo
STARTED   161   166   163 
COMPLETED   160   165   159 
NOT COMPLETED   1   1   4 
Adverse Event                0                1                1 
Physician Decision                1                0                0 
Protocol Violation                0                0                2 
Withdrawal by Subject                0                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TAU-284 Low TAU-284 5mg twice daily for 2 weeks
TAU-284 High TAU-284 10mg twice daily for 2 weeks
Placebo TAU-284 placebo twice daily for 2 weeks
Total Total of all reporting groups

Baseline Measures
   TAU-284 Low   TAU-284 High   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 161   166   163   490 
Age 
[Units: Years]
Mean (Standard Deviation)
 11.2  (2.5)   11.4  (2.3)   11.2  (2.5)   11.2  (2.4) 
Gender 
[Units: Participants]
       
Female   62   64   72   198 
Male   99   102   91   292 


  Outcome Measures

1.  Primary:   Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)   [ Time Frame: Baseline and Week 2 ]

2.  Secondary:   Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]   [ Time Frame: Week 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)   [ Time Frame: Week 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)   [ Time Frame: Week 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change From Baseline in Severity Score   [ Time Frame: Week 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Adverse Events and Adverse Drug Reactions   [ Time Frame: Week 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

7.  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)   [ Time Frame: Week 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
e-mail: cti-inq-ml@ml.mt-pharma.co.jp



Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01425632     History of Changes
Other Study ID Numbers: TAU-284-17
Study First Received: August 28, 2011
Results First Received: September 17, 2015
Last Updated: November 10, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare