Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01523236 | Clinical Equivalence Study of Mometasone Nasal Spray, 50 Mcg/Actuation | PHASE1 | COMPLETED | 800 | — | — | Dec 1, 2011 | Jan 1, 2012 | Feb 1, 2012 | - | — |
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Mometasone furoate | DRUG | 50 mcg/actuation Nasal Spray |
| Nasonex® | DRUG | 50 mcg/actuation Nasal Spray |
| Placebo | DRUG | Nasal Spray |
Inclusion Criteria: * Male or non-pregnant, non-lactating female 12 years or age or older. * Signed informed consent form, which meets all criteria of current FDA regulations. For patients under the age of majority in the state the study is being conducted (18 years in most states) the parent or le...