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Nasonex, 50 μg/actuation · 1 trial · 1 indication
The statistical analysis for both clinical equivalence and superiority of the active treatments over placebo will involve Analysis of Variance (ANOVA) and Analysis of Covariance (ANCOVA), respectively. 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.
| Arm | Type | Description |
|---|---|---|
| Mometasone Furoate Monohydrate Nasal Spray,50 μg/act. | ACTIVE_COMPARATOR | Days 1 through 7, each subject received a placebo run-in. Days 8 through 21, 2 sprays (2 × 50 μg) of Mometasone Furoate Monohydrate Nasal Spray per nostril once daily for 14 days. Total Daily Dose = 4 × 50 μg = 200 μg. |
| Nasonex® Nasal Spray, 50 μg/actuation | ACTIVE_COMPARATOR | Days 1 through 7, each subject received a placebo run-in. Days 8 through 21, 2 sprays (2 × 50 μg) of Nasonex® Nasal Spray per nostril once daily for 14 days, Total Daily Dose = 4 × 50 μg = 200 μg. |
| Nasonex® Nasal Spray Suspnsn, 50 μg/actuation | ACTIVE_COMPARATOR | Days 1 through 7, each subject received a placebo run-in. Days 8 through 21, 2 sprays (2 × 50 μg) of Nasonex® Nasal Spray Suspension per nostril once daily for 14 days, Total Daily Dose = 4 × 50 μg = 200 μg. |
| Placebo Nasal Spray, 50 μL/actuation | PLACEBO_COMPARATOR | Days 1 through 7, each subject received a placebo run-in. Days 8 through 21, 2 sprays of placebo nasal spray per nostril once daily. |
| Name | Type | Description |
|---|---|---|
| Mometasone Furoate Monohydrate Nasal Spray, 50 μg/act. | DRUG | - |
| Nasonex® Nasal Spray, 50 μg/actuation | DRUG | - |
| Nasonex® Nasal Spray Suspnsn, 50 μg/actuation | DRUG | - |
| Placebo Nasal Spray, 50 μL/actuation | DRUG | - |
Inclusion Criteria: 1. Age: 12 years of age or older. 2. Signed informed consent form. For patients under the age of majority, the parent or legal guardian should sign the consent form and the child will be required to sign a patient "assent" form. 3. Sex: Male and/or non-pregnant, non-lactating fe...
Nasonex 50 μg/actuation is used for the treatment of the signs and symptoms of seasonal allergic rhinitis. It is a small molecule drug being developed by Viatris Inc. for this indication. The drug is currently in Phase 1 clinical development.
Nasonex 50 μg/actuation is being developed by Viatris Inc., a company traded on the stock exchange under the ticker VTRS. The drug is intended for the treatment of the signs and symptoms of seasonal allergic rhinitis and is currently in Phase 1 clinical development.
Nasonex 50 μg/actuation is in Phase 1 clinical development. It is an investigational drug for the treatment of the signs and symptoms of seasonal allergic rhinitis. The drug has completed one clinical trial, and it is not yet approved by regulatory authorities.
Nasonex 50 μg/actuation has one completed clinical trial with the identifier NCT02109185. This Phase 1 study compared mometasone nasal spray, Nasonex nasal spray, Nasonex nasal spray suspension, and placebo for the treatment of seasonal allergies. The trial enrolled 1307 participants and was randomized, double-blind, and placebo-controlled.
Nasonex 50 μg/actuation is a mometasone nasal spray product. In the clinical trial NCT02109185, it was compared against other mometasone nasal spray formulations and placebo. The drug is being developed by Viatris Inc. for the treatment of seasonal allergic rhinitis.