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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

  Participant Flow

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 TAU-284 10mg twice daily for 12 weeks

Participant Flow:   Overall Study
    TAU-284
STARTED   58 
COMPLETED   56 
NOT COMPLETED   2 
Physician Decision                1 
Withdrawal by Subject                1 



  Baseline Characteristics

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 TAU-284 10mg twice daily for 12 weeks

Baseline Measures
   TAU-284 
Overall Participants Analyzed 
[Units: Participants]
 58 
Age 
[Units: Years]
Mean (Standard Deviation)
 11.2  (2.3) 
Gender 
[Units: Participants]
 
Female   25 
Male   33 


  Outcome Measures

1.  Primary:   Number of Patients With Adverse Events and Adverse Drug Reactions   [ Time Frame: Up to Week 12 ]

2.  Secondary:   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) ]

3.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)   [ Time Frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis   [ Time Frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Influence of Activities in Daily Life(Study, Outing, Sleeping)   [ Time Frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)   [ Time Frame: Week 12 or suspension ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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


Publications of Results:

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