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This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% Twice a day | Experimental | Bepotastine Besilate Nasal Spray 2% Twice a day |
|
| 3% Twice a day | Experimental | Bepotastine Besilate Nasal Spray 3% Twice a day |
|
| 4% Twice a day | Experimental | Bepotastine Besilate Nasal Spray 4% Twice a day |
|
| Placebo | Placebo Comparator | Placebo nasal spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepotastine Besilate Nasal Spray 2% Twice a day | Drug | nasal spray |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS | Total nasal symptom score (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms. Morning and evening scores were averaged. | Baseline, 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim McNamara, PharmD | ISTA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISTA Pharmaceuticals, Inc. | Irvine | California | 92618 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2% Twice a Day | Bepotastine Besilate Nasal Spray 2% Twice a day Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray |
| FG001 | 3% Twice a Day | Bepotastine Besilate Nasal Spray 3% Twice a day Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bepotastine Besilate Nasal Spray 3% Twice a day |
| Drug |
nasal spray |
|
| Bepotastine Besilate Nasal Spray 4% Twice a day | Drug | nasal spray |
|
| Placebo Nasal Spray | Drug | nasal spray |
|
| FG002 | 4% Twice a Day | Bepotastine Besilate Nasal Spray 4% Twice a day Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray |
| FG003 | Placebo | Placebo nasal spray Placebo Nasal Spray: nasal spray |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 2% Twice a Day | Bepotastine Besilate Nasal Spray 2% Twice a day Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray |
| BG001 | 3% Twice a Day | Bepotastine Besilate Nasal Spray 3% Twice a day Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray |
| BG002 | 4% Twice a Day | Bepotastine Besilate Nasal Spray 4% Twice a day Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray |
| BG003 | Placebo | Placebo nasal spray Placebo Nasal Spray: nasal spray |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS | Total nasal symptom score (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms. Morning and evening scores were averaged. | All randomized participants were included in the analysis population, with no imputation of missing data at 14 days. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 14 days |
|
|
|
14 days
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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 | 2% Twice a Day | Bepotastine Besilate Nasal Spray 2% Twice a day Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray | 0 | 150 | 0 | 150 | 25 | 150 |
| EG001 | 3% Twice a Day | Bepotastine Besilate Nasal Spray 3% Twice a day Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray | 1 | 150 | 1 | 150 | 22 | 150 |
| EG002 | 4% Twice a Day | Bepotastine Besilate Nasal Spray 4% Twice a day Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray | 0 | 149 | 0 | 149 | 22 | 149 |
| EG003 | Placebo | Placebo nasal spray Placebo Nasal Spray: nasal spray | 0 | 152 | 0 | 152 | 10 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild taste following instillation | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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Please contact sponsor directly for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 908-300-9920 | susan.harris@bauschhealth.com |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Male |
|