NCT01523236

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Mometasone furoate	50 mcg/actuation Nasal Spray
DRUG	Nasonex®	50 mcg/actuation Nasal Spray
DRUG	Placebo	Nasal Spray

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2012-02-01
• Last updated: 2012-02-01