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The objective of this study is to evaluate the clinical equivalence of the test formulation of mometasone furoate anhydrous 50 mcg/actuation nasal spray (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) to the marketed formulation Nasonex® (mometasone furoate monohydrate) nasal spray, 50 mcg/actuation (Schering) in patients with seasonal allergic rhinitis.
In addition, the efficacy of both the test and reference nasal sprays will be compared to a placebo nasal spray and safety will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Test Product | Experimental | Mometasone furoate anhydrous 50 mcg/actuation Nasal Spray (Teva) |
|
| Reference Listed Drug | Active Comparator | Nasonex® (mometasone furoate monohydrate) 50 mcg/actuation Nasal Spray (Schering) |
|
| Placebo | Placebo Comparator | Saline Placebo Nasal Spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone furoate | Drug | 50 mcg/actuation Nasal Spray |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline for mean reflective Total Nasal Symptom Score (rTNSS) | The statistical analysis for both clinical equivalence and superiority of the active treatments over placebo will involve Analysis of Covariance (ANCOVA). The Per-Protocol Population (PPP) will be used for the primary analysis of bioequivalence. The Intent-to-Treat Population (ITT) will be used for the primary analysis of superiority. | 2 week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in the mean Instantaneous Total Nasal Symptom Score (iTNSS) | Mean values will be presented for the secondary efficacy variable. Statistical analysis will be performed by ANCOVA. | 2 week treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 6, 2020 | |
| Reset | Oct 28, 2020 | |
| Release | May 11, 2023 | |
| Reset | May 11, 2023 | |
| Release | Aug 19, 2024 | |
| Reset | Aug 21, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 6, 2020 | Oct 28, 2020 | |||
| May 11, 2023 |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Nasonex® |
| Drug |
50 mcg/actuation Nasal Spray |
|
|
| Placebo | Drug | Nasal Spray |
|
| May 11, 2023 |
| Aug 19, 2024 | Aug 21, 2024 |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |