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The objectives of this study is to demonstrate bioequivalence (comparable safety and efficacy) of the Test product to the Reference in the treatment of subjects seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental | Mometasone furoate 50 mcg/actuation Nasal Spray |
|
| Reference product | Active Comparator | Nasonex Nasal Spray |
|
| Placebo Nasal Spray | Placebo Comparator | vehicle of the test product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone furoate | Drug |
| ||
| Nasonex Nasal Spray |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline for mean reflective Total Nasal Symptom Score (rTNSS) | 2 week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in the mean Instantaneous Total Nasal Symptom Score (iTNSS) | 2 weeks treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio | Texas | United States |
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|
| Placebo nasal spray | Drug |
|
| 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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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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