Trial Outcomes & Findings for A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (NCT NCT01425632)

NCT ID: NCT01425632

Last Updated: 2026-01-07

Results Overview

Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 490 participants
• Primary outcome timeframe: Baseline and Week 2
• Results posted on: 2026-01-07

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	161	166	163
Overall Study COMPLETED	160	165	159
Overall Study NOT COMPLETED	1	1	4

Reasons for withdrawal

Measure	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
Overall Study Adverse Event	0	1	1
Overall Study Physician Decision	1	0	0
Overall Study Protocol Violation	0	0	2
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	TAU-284 Low n=161 Participants TAU-284 5mg twice daily for 2 weeks	TAU-284 High n=166 Participants TAU-284 10mg twice daily for 2 weeks	Placebo n=163 Participants TAU-284 placebo twice daily for 2 weeks	Total n=490 Participants Total of all reporting groups
Age, Continuous	11.2 years STANDARD_DEVIATION 2.5 • n=37 Participants	11.4 years STANDARD_DEVIATION 2.3 • n=56 Participants	11.2 years STANDARD_DEVIATION 2.5 • n=95 Participants	11.2 years STANDARD_DEVIATION 2.4 • n=61 Participants
Sex: Female, Male Female	62 Participants n=37 Participants	64 Participants n=56 Participants	72 Participants n=95 Participants	198 Participants n=61 Participants
Sex: Female, Male Male	99 Participants n=37 Participants	102 Participants n=56 Participants	91 Participants n=95 Participants	292 Participants n=61 Participants

PRIMARY outcome

Timeframe: Baseline and Week 2

Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .

Outcome measures

Measure	TAU-284 Low n=161 Participants TAU-284 5mg twice daily for 2 weeks	TAU-284 High n=166 Participants TAU-284 10mg twice daily for 2 weeks	Placebo n=163 Participants TAU-284 placebo twice daily for 2 weeks
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)	-0.84 units on a scale Standard Error 0.12	-0.92 units on a scale Standard Error 0.12	-0.70 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Week 2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 2

Outcome measures

Outcome data not reported

Adverse Events

TAU-284 Low

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

TAU-284 High

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TAU-284 Low n=161 participants at risk TAU-284 5mg twice daily for 2 weeks	TAU-284 High n=166 participants at risk TAU-284 10mg twice daily for 2 weeks	Placebo n=163 participants at risk TAU-284 placebo twice daily for 2 weeks
Infections and infestations Nasopharyngitis	5.0% 8/161	1.8% 3/166	6.7% 11/163
Infections and infestations Pharyngitis	3.1% 5/161	1.2% 2/166	2.5% 4/163
Respiratory, thoracic and mediastinal disorders Epistaxis	3.1% 5/161	2.4% 4/166	0.00% 0/163

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Email: cti-inq-ml.JP@ml.tanabe-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER