NCT00564421
Completed
Phase 3
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
ConditionsSeasonal Allergic Rhinitis
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 798
- Primary Endpoint
- Change in nasal symptom scores
Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Epinastine low concentration:low dose volume
Experimental
Intervention: epinastine nasal spray, low concentration, low dose volume (Drug)
Epinastine low concentration:high dose volume
Experimental
Intervention: epinastine nasal spray, low concentration, high dose volume (Drug)
Epinastine high concentration:low dose volume
Experimental
Intervention: epinastine nasal spray, high concentration, low dose volume (Drug)
Epinastine high concentration:high dose volume
Experimental
Intervention: epinastine nasal spray, high concentration, high dose volume (Drug)
Placebo nasal spray
Placebo Comparator
Intervention: placebo nasal spray (Other)
Outcomes
Primary Outcomes
Change in nasal symptom scores
Time Frame: 14 days
Secondary Outcomes
- Change in ocular symptom scores and quality of life scores(14 days)
- Standard safety assessments(14 days)
Investigators
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