NCT01038427

A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Mometasone Nasal Spray (Lek Pharmaceuticals) 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: 795 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study compared the efficacy and safety of a generic mometasone nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.

Detailed description

The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of mometasone furoate monohydrate, 50 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Nasonex® nasal spray (Schering) in the relief of the signs and symptoms of seasonal allergic rhinitis. Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo) for 14 days of treatment. In all treatment groups, participants were instructed to administer the study drug once daily at approximately the same time each day. A single dose of 200 mcg was 4 actuations, each containing 50 mcg per actuation. Patients were instructed to administer the 4 actuations alternating between right and left nostril, such that 2 actuations were not administered back to back to the same nostril.

Conditions

• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
DRUG	Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals)	Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
DRUG	Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray	Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
DRUG	Placebo	Placebo nasal spray administered once daily (4 actuations) for 14 days.

Timeline

• Start date: 2009-12-02
• Primary completion: 2010-02-16
• Completion: 2010-02-16
• First posted: 2009-12-24
• Last updated: 2021-02-03
• Results posted: 2021-02-03

Locations

8 sites across 1 country: United States