Trial Outcomes & Findings for The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (NCT NCT01861522)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

473 participants

Primary outcome timeframe

Baseline and Week 2

Results posted on

2026-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	TAU-284 TAU-284 10mg twice daily for 2 weeks	Placebo TAU-284 placebo twice daily for 2 weeks
Overall Study STARTED	240	232
Overall Study COMPLETED	237	232
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	TAU-284 TAU-284 10mg twice daily for 2 weeks	Placebo TAU-284 placebo twice daily for 2 weeks
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAU-284 n=240 Participants TAU-284 10mg twice daily for 2 weeks	Placebo n=232 Participants TAU-284 placebo twice daily for 2 weeks	Total n=472 Participants Total of all reporting groups
Age, Continuous	10.3 years STANDARD_DEVIATION 2.4 • n=18 Participants	10.4 years STANDARD_DEVIATION 2.4 • n=17 Participants	10.4 years STANDARD_DEVIATION 2.4 • n=35 Participants
Sex: Female, Male Female	108 Participants n=18 Participants	92 Participants n=17 Participants	200 Participants n=35 Participants
Sex: Female, Male Male	132 Participants n=18 Participants	140 Participants n=17 Participants	272 Participants n=35 Participants

PRIMARY outcome

Timeframe: Baseline and Week 2

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).

Outcome measures

Outcome measures
Measure	TAU-284 n=240 Participants TAU-284 10mg twice daily for 2 weeks	Placebo n=232 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]	-1.579 units on a scale Standard Error 0.090	-1.110 units on a scale Standard Error 0.092

SECONDARY outcome

Timeframe: baseline, Week1 and Week 2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, Week1 and Week 2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, Week1 and Week 2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Randomization, Week1 and Week 2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 2

Outcome measures

Outcome data not reported

Adverse Events

TAU-284

Serious events: 0 serious events

Other events: 17 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

Other adverse events
Measure	TAU-284 n=240 participants at risk TAU-284 10mg twice daily for 2 weeks	Placebo n=232 participants at risk TAU-284 placebo twice daily for 2 weeks
Infections and infestations Pharyngitis	4.2% 10/240	2.6% 6/232
Infections and infestations Nasopharyngitis	2.9% 7/240	3.9% 9/232

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