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

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ClinicalTrials.gov Identifier: NCT01861522
Recruitment Status : Completed
First Posted : May 23, 2013
Results First Posted : December 15, 2015
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Perennial Allergic Rhinitis
Interventions Drug: Bepotastine besilate
Drug: Placebo
Enrollment 473
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TAU-284 Placebo
Hide Arm/Group Description TAU-284 10mg twice daily for 2 weeks TAU-284 placebo twice daily for 2 weeks
Period Title: Overall Study
Started 240 232 [1]
Completed 237 232
Not Completed 3 0
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             2             0
[1]
One subject who did not receive any study drug was excluded from the FAS and the Safety Analysis Set
Arm/Group Title TAU-284 Placebo Total
Hide Arm/Group Description TAU-284 10mg twice daily for 2 weeks TAU-284 placebo twice daily for 2 weeks Total of all reporting groups
Overall Number of Baseline Participants 240 232 472
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 240 participants 232 participants 472 participants
10.3  (2.4) 10.4  (2.4) 10.4  (2.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants 232 participants 472 participants
Female
108
  45.0%
92
  39.7%
200
  42.4%
Male
132
  55.0%
140
  60.3%
272
  57.6%
1.Primary Outcome
Title Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
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 symptoms) to 4 (very severe).
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TAU-284 Placebo
Hide Arm/Group Description:
TAU-284 10mg twice daily for 2 weeks
TAU-284 placebo twice daily for 2 weeks
Overall Number of Participants Analyzed 240 232
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.579  (0.090) -1.110  (0.092)
2.Secondary Outcome
Title Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
Hide Description [Not Specified]
Time Frame baseline, Week1 and Week 2
Outcome Measure Data Not Reported
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, Week1 and Week 2
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 baseline, Week1 and Week 2
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 Randomization, Week1 and Week 2
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Adverse Events and Adverse Drug Reactions
Hide Description [Not Specified]
Time Frame Week 2
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TAU-284 Placebo
Hide Arm/Group Description TAU-284 10mg twice daily for 2 weeks TAU-284 placebo twice daily for 2 weeks
All-Cause Mortality
TAU-284 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TAU-284 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/240 (0.00%)   0/232 (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 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   17/240 (7.08%)   15/232 (6.47%) 
Infections and infestations     
Pharyngitis  10/240 (4.17%)  6/232 (2.59%) 
Nasopharyngitis  7/240 (2.92%)  9/232 (3.88%) 
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
Layout table for Results Point of Contact information
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
EMail: cti-inq-ml@ml.mt-pharma.co.jp
Layout table for additonal information
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01861522     History of Changes
Other Study ID Numbers: TAU-284-20
First Submitted: May 19, 2013
First Posted: May 23, 2013
Results First Submitted: September 17, 2015
Results First Posted: December 15, 2015
Last Update Posted: December 15, 2015