Trial · NCT01861522
The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
NCT01861522, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2015-12-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis. Trials, record NCT01861522. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01861522
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
- NCT number
- NCT01861522
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 473 participants, actual
- Lead sponsor
- Tanabe Pharma Corporation
- Conditions
- Perennial Allergic Rhinitis
- Interventions
- Bepotastine besilate, Placebo
- First posted
- 2013-05-23
- Last updated
- 2026-01-08
- Results first posted
- 2015-12-15
Source ClinicalTrials.gov
Registered outcomes6
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] | 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). |
| Secondary | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] | baseline, Week1 and Week 2 | |
| Secondary | Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) | baseline, Week1 and Week 2 | |
| Secondary | Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) | baseline, Week1 and Week 2 | |
| Secondary | Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis | Randomization, Week1 and Week 2 | |
| Secondary | Adverse Events and Adverse Drug Reactions | Week 2 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] | 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] | baseline, Week1 and Week 2 | |||
| SECONDARY | Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) | baseline, Week1 and Week 2 | |||
| SECONDARY | Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) | baseline, Week1 and Week 2 | |||
| SECONDARY | Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis | Randomization, Week1 and Week 2 | |||
| SECONDARY | Adverse Events and Adverse Drug Reactions | Week 2 |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] | TAU-284 | -1.579 | Standard Error 0.090 | units on a scale | |
| Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] | Placebo | -1.110 | Standard Error 0.092 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAU-284 | 240 | |
| Overall Study | STARTED | Placebo | 232 | |
| Overall Study | COMPLETED | TAU-284 | 237 | |
| Overall Study | COMPLETED | Placebo | 232 | |
| Overall Study | NOT COMPLETED | TAU-284 | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Events |
|---|---|---|---|---|---|---|
| other | Pharyngitis | Infections and infestations | TAU-284 | 10 | 240 | |
| other | Pharyngitis | Infections and infestations | Placebo | 6 | 232 | |
| other | Nasopharyngitis | Infections and infestations | TAU-284 | 7 | 240 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 9 | 232 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAU-284 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | TAU-284 | 17 | 240 |
| Total, other adverse events | Placebo | 15 | 232 |
| Total, serious adverse events | TAU-284 | 0 | 240 |
| Total, serious adverse events | Placebo | 0 | 232 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26364765 | RESULT |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| TAU-284 vs Placebo: serious adverse events |
Source Trial comparisons
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.
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/NCT01861522
GET https://conductscience.org/api/trials/v1/NCT01861522/registered