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A randomized, double-blind, placebo-controlled parallel-group study, comparing the bioequivalence of triamcinolone acetonide aqueous nasal spray (Apotex, Inc.) to that of Nasacort® AQ nasal spray (Sanofi-Aventis Pharmaceutical Products, Inc.) in the treatment of seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| triamcinolone acetonide aqueous nasal spray | Experimental |
| |
| Nasacort® AQ Nasal Spray | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triamcinolone acetonide aqueous nasal spray (Apotex Inc.) | Drug | It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day. |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate similar efficacy (bioequivalence) of the generic triamcinolone acetonide aqueous nasal spray (Apotex, Inc.) with that of the marketed reference drug, Nasacort® AQ Nasal Spray in the treatment of seasonal allergic rhinitis. |
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Inclusion Criteria:
Exclusion Criteria:
Time prior to Visit 2
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinsys Clinical Research, Inc. | Bedminster | New Jersey | 07921 | United States |
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| triamcinolone acetonide aqueous nasal spray (Nasacort® AQ) | Drug | It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day. |
|
| Placebo | Drug | It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day. |
|
| 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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