A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis
Phase 2
Completed
- Conditions
- Seasonal Allergic Rhinitis
- Registration Number
- NCT00407927
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this trial is to determine the safety, efficacy and tolerability of two doses of the study drug compared to placebo for the treatment of subjects with seasonal allergic rhinitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 571
Inclusion Criteria
- A documented history of seasonal allergic rhinitis to mountain cedar pollen
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Exclusion Criteria
- Significant medical condition
- Cardiovascular abnormality
- Have a significant physical obstruction in the nose
- Started or had a change in immunotherapy within the 30 days prior to
screening
- Have nasal ulceration(s) or any active nasal bleeding
- Require use of allergy medications during the study
- Require use of asthma medications other than as needed albuterol
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in nasal symptom scores
- Secondary Outcome Measures
Name Time Method Change in non-nasal symptom scores and quality of life scores Standard safety assessments
Trial Locations
- Locations (7)
Allergy Asthma Research Institute
🇺🇸Waco, Texas, United States
Biogenics Research Institute
🇺🇸San Antonio, Texas, United States
Allergy & Asthma Associates
🇺🇸Austin, Texas, United States
Lovelace Scientific Resources, Inc.
🇺🇸Austin, Texas, United States
Central Texas Health Research
🇺🇸New Braunfels, Texas, United States
Sylvana Research Associates
🇺🇸San Antonio, Texas, United States
Kerrville Research Associates
🇺🇸Kerrville, Texas, United States