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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 safety of TAU-284.
This is a randomized, double-blind, placebo-controlled, 2-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (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 safety of TAU-284.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAU-284 | Experimental | Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed). |
|
| Placebo | Placebo Comparator | Two placebo tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepotastine besilate | Drug | Two TAU-284 5mg tablets will be taken orally twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] | 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). | 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] | baseline, Week1 and 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 | Nippon Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reserch site | Fukuoka | Japan | ||||
| Reserch site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26364765 | Result | Okubo K, Ichimura M, Koyama T, Susuta Y, Izaki H. Double-blind placebo-controlled study of bepotastine besilate in pediatric patients with perennial allergic rhinitis. Expert Opin Pharmacother. 2015;16(16):2395-408. doi: 10.1517/14656566.2015.1085511. Epub 2015 Sep 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TAU-284 | TAU-284 10mg twice daily for 2 weeks |
| FG001 | 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 | TAU-284 10mg twice daily for 2 weeks |
| BG001 | Placebo | TAU-284 placebo 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] | 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). | 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 | TAU-284 10mg twice daily for 2 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngitis | Infections and infestations | MedDRA 16.1 |
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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 |
|---|---|
| C511534 | bepotastine besilate |
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| Placebo | Drug | Two Placebo tablets will be taken orally twice a day |
|
| baseline, Week1 and Week 2 |
| Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) | baseline, Week1 and Week 2 |
| Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis | Randomization, Week1 and Week 2 |
| Adverse Events and Adverse Drug Reactions | Week 2 |
| Toyama |
| Japan |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] | Not Posted | baseline, Week1 and Week 2 | Participants |
| Secondary | Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) | Not Posted | baseline, Week1 and Week 2 | Participants |
| Secondary | Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) | Not Posted | baseline, Week1 and Week 2 | Participants |
| Secondary | Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis | Not Posted | Randomization, Week1 and Week 2 | Participants |
| Secondary | Adverse Events and Adverse Drug Reactions | Not Posted | Week 2 | Participants |
| 0 |
| 240 |
| 17 |
| 240 |
| EG001 | Placebo | TAU-284 placebo twice daily for 2 weeks | 0 | 232 | 15 | 232 |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |