Trial Outcomes & Findings for A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (NCT NCT01900054)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

58 participants

Primary outcome timeframe

Up to Week 12

Results posted on

2026-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	TAU-284 TAU-284 10mg twice daily for 12 weeks
Overall Study STARTED	58
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	TAU-284 TAU-284 10mg twice daily for 12 weeks
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAU-284 n=58 Participants TAU-284 10mg twice daily for 12 weeks
Age, Continuous	11.2 years STANDARD_DEVIATION 2.3 • n=9 Participants
Sex: Female, Male Female	25 Participants n=9 Participants
Sex: Female, Male Male	33 Participants n=9 Participants

PRIMARY outcome

Timeframe: Up to Week 12

Outcome measures

Outcome measures
Measure	TAU-284 n=58 Participants TAU-284 10mg twice daily for 12 weeks
Number of Patients With Adverse Events and Adverse Drug Reactions Adverse drug reactions	2 participants
Number of Patients With Adverse Events and Adverse Drug Reactions Adverse events	37 participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	TAU-284 n=58 Participants TAU-284 10mg twice daily for 12 weeks
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. Week 2	-0.943 units on a scale Standard Deviation 1.549
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. Week 4	-1.388 units on a scale Standard Deviation 1.465
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. Week 6	-1.321 units on a scale Standard Deviation 1.844
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. Week 8	-1.433 units on a scale Standard Deviation 1.880
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. Week 10	-1.460 units on a scale Standard Deviation 1.777
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. Week 12	-1.451 units on a scale Standard Deviation 1.707
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. final evaluation point	-1.440 units on a scale Standard Deviation 1.678

SECONDARY outcome

Timeframe: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 12 or suspension

Outcome measures

Outcome data not reported

Adverse Events

TAU-284

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TAU-284 n=58 participants at risk TAU-284 10mg twice daily for 12 weeks
Infections and infestations Nasopharyngitis	32.8% 19/58
Infections and infestations Otitis externa	5.2% 3/58
Infections and infestations Pharyngitis	5.2% 3/58
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	8.6% 5/58
Respiratory, thoracic and mediastinal disorders Epistaxis	3.4% 2/58
Skin and subcutaneous tissue disorders Eczema	3.4% 2/58
Investigations Liver function test abnormal	3.4% 2/58

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER