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

Merck Sharp & Dohme LLC798 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

798

Conditions

Seasonal Allergic Rhinitis

Interventions

epinastine nasal spray, low concentration, low dose volumeDRUG

2 sprays in each nostril, dosed twice a day

placebo nasal sprayOTHER

2 sprays in each nostril, dosed twice a day

epinastine nasal spray, low concentration, high dose volumeDRUG

2 sprays in each nostril, dosed twice a day

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A documented history of seasonal allergic rhinitis to mountain cedar or other spring pollen Exclusion Criteria: * Significant medical condition * Significant nasal abnormality * Significant cardiac condition * Recent infection * Use of other allergy medication during the study * Use of asthma medication other than as-needed albuterol

Outcomes

Primary Outcomes

Change in nasal symptom scores

Time frame: 14 days

Secondary Outcomes

Change in ocular symptom scores and quality of life scores

Time frame: 14 days

Standard safety assessments

Time frame: 14 days

Data from ClinicalTrials.gov

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