NCT00564421

Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)

A Phase 3 Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple Dose Safety and Efficacy Study of Epinastine Nasal Spray vs. Placebo in Subjects With Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 798 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of epinastine nasal spray compared to placebo for the treatment of subjects with seasonal allergic rhinitis

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	epinastine nasal spray, low concentration, low dose volume	2 sprays in each nostril, dosed twice a day
OTHER	placebo nasal spray	2 sprays in each nostril, dosed twice a day
DRUG	epinastine nasal spray, low concentration, high dose volume	2 sprays in each nostril, dosed twice a day
DRUG	epinastine nasal spray, high concentration, low dose volume	2 sprays in each nostril, dosed twice a day
DRUG	epinastine nasal spray, high concentration, high dose volume	2 sprays in each nostril, dosed twice a day

Timeline

• Start date: 2007-12-18
• Primary completion: 2008-02-14
• Completion: 2008-02-14
• First posted: 2007-11-28
• Last updated: 2017-03-24