At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals), Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray, and 1 other intervention for Rhinitis, Allergic, Seasonal. Completed, enrolled 795 participants across 8 sites.
Detailed 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.
Study Details
Timeline
Interventions
Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
Placebo nasal spray administered once daily (4 actuations) for 14 days.