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The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis, and to investigate the dose response, safety, and plasma concentrations of TAU-284.
This is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (10 mg/day or 20 mg/day) or placebo to pediatric patients with perennial allergic rhinitis, with "the change from baseline in total nasal symptom score (total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion])" as the primary endpoint; and to investigate the dose response, safety, and plasma concentrations of TAU-284.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAU-284 Low | Experimental |
| |
| TAU-284 High | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAU-284 | Drug | TAU-284 Low |
| |
| TAU-284 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation) | 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) . | Baseline and Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] | Week 2 | |
| Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimihiro Okubo, M.D. Ph.D. | Department of Otorhinolaryngology, Nippon Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reserch site | Chūbu | Japan | ||||
| Reserch site |
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| ID | Title | Description |
|---|---|---|
| FG000 | TAU-284 Low | TAU-284 5mg twice daily for 2 weeks |
| FG001 | TAU-284 High | TAU-284 10mg twice daily for 2 weeks |
| FG002 | Placebo | TAU-284 placebo twice daily for 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TAU-284 Low | TAU-284 5mg twice daily for 2 weeks |
| BG001 | TAU-284 High | TAU-284 10mg twice daily for 2 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation) | 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) . | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 2 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAU-284 Low | TAU-284 5mg twice daily for 2 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C108476 | bepotastine |
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| Drug |
TAU-284 High |
|
| Placebo | Drug | Placebo |
|
| Week 2 |
| Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) | Week 2 |
| Change From Baseline in Severity Score | Week 2 |
| Adverse Events and Adverse Drug Reactions | Week 2 |
| 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 |
| Hokuriku |
| Japan |
| Reserch site | Kanto | Japan |
| Reserch site | Kinki | Japan |
| Reserch site | Kyusyu | Japan |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 |
| Placebo |
TAU-284 placebo twice daily for 2 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
TAU-284 placebo twice daily for 2 weeks |
|
|
| Secondary | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] | Not Posted | Week 2 | Participants |
| Secondary | Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) | Not Posted | Week 2 | Participants |
| Secondary | Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) | Not Posted | Week 2 | Participants |
| Secondary | Change From Baseline in Severity Score | Not Posted | Week 2 | Participants |
| Secondary | Adverse Events and Adverse Drug Reactions | Not Posted | Week 2 | Participants |
| 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) | Not Posted | Week 2 | Participants |
| 0 |
| 161 |
| 17 |
| 161 |
| EG001 | TAU-284 High | TAU-284 10mg twice daily for 2 weeks | 0 | 166 | 8 | 166 |
| EG002 | Placebo | TAU-284 placebo twice daily for 2 weeks | 0 | 163 | 15 | 163 |
| Pharyngitis | Infections and infestations | MedDRA 14.1 |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |