Clinical Equivalence Study of Mometasone Nasal Spray, 50 Mcg/Actuation

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01523236
Study type	Interventional
Source	Teva Pharmaceuticals USA
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	December 2011
Completion date	January 2012

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