Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mometasone Furoate, 50 μg/act · 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...