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| ID | Type | Description | Link |
|---|---|---|---|
| 033-103 |
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The purpose of this study is to determine the safety and efficacy of epinastine nasal spray compared to placebo for the treatment of subjects with seasonal allergic rhinitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epinastine low concentration:low dose volume | Experimental |
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| Epinastine low concentration:high dose volume | Experimental |
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| Epinastine high concentration:low dose volume | Experimental |
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| Epinastine high concentration:high dose volume | Experimental |
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| Placebo nasal spray | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epinastine nasal spray, low concentration, low dose volume | Drug | 2 sprays in each nostril, dosed twice a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in nasal symptom scores | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ocular symptom scores and quality of life scores | 14 days | |
| Standard safety assessments | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Kellerman, PharmD | Merck Sharp & Dohme LLC | Study Director |
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| placebo nasal spray | Other | 2 sprays in each nostril, dosed twice a day |
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| epinastine nasal spray, low concentration, high dose volume | Drug | 2 sprays in each nostril, dosed twice a day |
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| epinastine nasal spray, high concentration, low dose volume | Drug | 2 sprays in each nostril, dosed twice a day |
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| epinastine nasal spray, high concentration, high dose volume | Drug | 2 sprays in each nostril, dosed twice a day |
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| 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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