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The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Low Dose | Experimental | bepotastine besilate nasal product - low dose |
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| Arm 2 - Medium Dose | Experimental | bepotastine besilate nasal product - medium dose |
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| Arm 3 - High Dose | Experimental | bepotastine besilate nasal product - high dose |
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| Arm 4 - Placebo | Placebo Comparator | placebo comparator nasal product |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bepotastine besilate nasal product - low dose | Drug | sterile nasal product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS | Total nasal symptom scores (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were 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 maximum score for increased allergic response of 12 units. The minimum possible total score was 0. | Baseline, 20 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 | Placebo | placebo comparator nasal product placebo comparator nasal product: sterile nasal product twice daily |
| FG001 | Low Dose - 2% | bepotastine besilate nasal product - low dose bepotastine besilate nasal product - low dose: sterile nasal product twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| bepotastine besilate nasal product - medium dose |
| Drug |
sterile nasal product |
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| bepotastine besilate nasal product - high dose | Drug | sterile nasal product |
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| placebo comparator nasal product | Drug | sterile nasal product |
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| FG002 | Medium Dose - 4% | bepotastine besilate nasal product - medium dose bepotastine besilate nasal product - medium dose: sterile nasal product twice daily |
| FG003 | High Dose - 6% | bepotastine besilate nasal product - high dose bepotastine besilate nasal product - high dose: sterile nasal product twice daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo comparator nasal product placebo comparator nasal product: sterile nasal product twice daily |
| BG001 | Low Dose - 2% | bepotastine besilate nasal product - low dose bepotastine besilate nasal product - low dose: sterile nasal product twice daily |
| BG002 | Medium Dose - 4% | bepotastine besilate nasal product - medium dose bepotastine besilate nasal product - medium dose: sterile nasal product twice daily |
| BG003 | High Dose - 6% | bepotastine besilate nasal product - high dose bepotastine besilate nasal product - high dose: sterile nasal product twice daily |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 Instantaneous TNSS | Total nasal symptom scores (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were 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 maximum score for increased allergic response of 12 units. The minimum possible total score was 0. | The per protocol population was based on participants who completed the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 20 days |
|
|
|
20 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 | Placebo | placebo comparator nasal product placebo comparator nasal product: sterile nasal product twice daily | 0 | 21 | 0 | 21 | 7 | 21 |
| EG001 | Low Dose - 2% | bepotastine besilate nasal product - low dose bepotastine besilate nasal product - low dose: sterile nasal product twice daily | 0 | 23 | 0 | 23 | 9 | 23 |
| EG002 | Medium Dose - 4% | bepotastine besilate nasal product - medium dose bepotastine besilate nasal product - medium dose: sterile nasal product twice daily | 0 | 22 | 0 | 22 | 9 | 22 |
| EG003 | High Dose - 6% | bepotastine besilate nasal product - high dose bepotastine besilate nasal product - high dose: sterile nasal product twice daily | 0 | 23 | 0 | 23 | 11 | 23 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild taste following instillation | General disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
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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 |
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| Day 20 (after twice daily dosing) |
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