Clinical Equivalence Study of Mometasone Nasal Spray, 50 Mcg/Actuation
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|ClinicalTrials.gov Identifier: NCT01523236|
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : February 1, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Seasonal Allergic Rhinitis||Drug: Mometasone furoate Drug: Nasonex® Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Mometasone Furoate Anhydrous, 50 Mcg/Actuation Nasal Spray (Teva Pharmaceuticals USA) Compared to Nasonex® (Mometasone Furoate Monohydrate) 50 Mcg/Actuation Nasal Spray (Schering) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Experimental: Investigational Test Product
Mometasone furoate anhydrous 50 mcg/actuation Nasal Spray (Teva)
Drug: Mometasone furoate
50 mcg/actuation Nasal Spray
Active Comparator: Reference Listed Drug
Nasonex® (mometasone furoate monohydrate) 50 mcg/actuation Nasal Spray (Schering)
50 mcg/actuation Nasal Spray
Other Name: Mometasone furoate (generic name)
Placebo Comparator: Placebo
Saline Placebo Nasal Spray
- Mean Change from Baseline for mean reflective Total Nasal Symptom Score (rTNSS) [ Time Frame: 2 week treatment period ]
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.
- Mean Change from Baseline in the mean Instantaneous Total Nasal Symptom Score (iTNSS) [ Time Frame: 2 week treatment period ]Mean values will be presented for the secondary efficacy variable. Statistical analysis will be performed by ANCOVA.