Approval Probability
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Adjusted LOA
ML Risk
Mometasone furoate · 1 trial · 1 indication
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...
Mometasone furoate is a small molecule being developed by Teva Pharmaceutical Industries Limited for the treatment of Seasonal Allergic Rhinitis. It is administered as a nasal spray at a dose of 50 mcg per actuation. The drug is currently in Phase 1 clinical development for this indication.
Mometasone furoate is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is in Phase 1 clinical development for Seasonal Allergic Rhinitis, with one completed clinical trial involving 800 participants.
Mometasone furoate is in Phase 1 clinical development. It is an investigational drug for Seasonal Allergic Rhinitis and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, with no active trials currently ongoing.
Mometasone furoate has one completed clinical trial registered under NCT01523236, titled 'Clinical Equivalence Study of Mometasone Nasal Spray, 50 Mcg/Actuation'. This Phase 1 trial enrolled 800 participants with Seasonal Allergic Rhinitis, was randomized, double-blind, and placebo-controlled, and included individuals aged 12 years and older.
Mometasone furoate is the active ingredient in the mometasone nasal spray being studied. The clinical trial NCT01523236 evaluates the nasal spray formulation containing 50 mcg of mometasone furoate per actuation for the treatment of Seasonal Allergic Rhinitis.