Trial · NCT01425632

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

NCT01425632, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2015-12-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis. Trials, record NCT01425632. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01425632

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
NCT number: NCT01425632
Status: Completed
Phases: Phase 3
Enrollment: 490 participants, actual
Lead sponsor: Tanabe Pharma Corporation
Conditions: Perennial Allergic Rhinitis
Interventions: TAU-284, TAU-284, Placebo
First posted: 2011-08-30
Last updated: 2026-01-07
Results first posted: 2015-12-14

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)	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) .
Secondary	Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]	Week 2
Secondary	Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)	Week 2
Secondary	Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)	Week 2
Secondary	Change From Baseline in Severity Score	Week 2
Secondary	Adverse Events and Adverse Drug Reactions	Week 2
Secondary	Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2)	Week 2

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)	Baseline and Week 2	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]	Week 2
SECONDARY	Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)	Week 2
SECONDARY	Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)	Week 2
SECONDARY	Change From Baseline in Severity Score	Week 2
SECONDARY	Adverse Events and Adverse Drug Reactions	Week 2
SECONDARY	Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2)	Week 2

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)	TAU-284 Low	-0.84	Standard Error 0.12	units on a scale
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)	TAU-284 High	-0.92	Standard Error 0.12	units on a scale
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)	Placebo	-0.70	Standard Error 0.12	units on a scale

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	TAU-284 Low	161
Overall Study	STARTED	TAU-284 High	166
Overall Study	STARTED	Placebo	163
Overall Study	COMPLETED	TAU-284 Low	160
Overall Study	COMPLETED	TAU-284 High	165
Overall Study	COMPLETED	Placebo	159
Overall Study	NOT COMPLETED	TAU-284 Low	1
Overall Study	NOT COMPLETED	TAU-284 High	1
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events9

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	TAU-284 Low	8	161
other	Nasopharyngitis	Infections and infestations	TAU-284 High	3	166
other	Nasopharyngitis	Infections and infestations	Placebo	11	163
other	Pharyngitis	Infections and infestations	TAU-284 Low	5	161
other	Pharyngitis	Infections and infestations	TAU-284 High	2	166
other	Pharyngitis	Infections and infestations	Placebo	4	163
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	TAU-284 Low	5	161
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	TAU-284 High	4	166
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Placebo	0	163

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TAU-284 Low
Total, all-cause mortality	TAU-284 High
Total, all-cause mortality	Placebo
Total, other adverse events	TAU-284 Low	17	161
Total, other adverse events	TAU-284 High	8	166
Total, other adverse events	Placebo	15	163
Total, serious adverse events	TAU-284 Low	0	161
Total, serious adverse events	TAU-284 High	0	166
Total, serious adverse events	Placebo	0	163

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01425632

GET https://conductscience.org/api/trials/v1/NCT01425632/registered

API reference For AI assistants