NCT02125253

Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg With Nasonex Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

A Blinded, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg (Amneal Pharmaceuticals LLC) With NASONEX® Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 811 (actual)
• Sponsor: Amneal Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the therapeutic equivalence of the lest formulation of Mometasone Furoate Nasal Spray, 50 mcg to the marketed formulation NASONEX® (mometasone furoate monohydrate) Nasal Spray, 50 mcg/actuation in patients with seasonal allergic rhinitis

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Mometasone Furoate Nasal Spray, 50 mcg	a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate
DRUG	Nasonex Nasal Spray, 50 mcg	a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate
DRUG	Placebo Nasal Spray	a metered-dose, manual pump spray unit containing an aqueous suspension

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-03-01
• Completion: 2014-06-01
• First posted: 2014-04-29
• Last updated: 2015-11-02

Locations

10 sites across 1 country: United States