Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)
Phase 3
Completed
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Registration Number
- NCT00564421
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 798
Inclusion Criteria
- A documented history of seasonal allergic rhinitis to mountain cedar or other spring pollen
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epinastine high concentration:high dose volume epinastine nasal spray, high concentration, high dose volume - Epinastine low concentration:high dose volume epinastine nasal spray, low concentration, high dose volume - Epinastine high concentration:low dose volume epinastine nasal spray, high concentration, low dose volume - Epinastine low concentration:low dose volume epinastine nasal spray, low concentration, low dose volume - Placebo nasal spray placebo nasal spray -
- Primary Outcome Measures
Name Time Method Change in nasal symptom scores 14 days
- Secondary Outcome Measures
Name Time Method Change in ocular symptom scores and quality of life scores 14 days Standard safety assessments 14 days