Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis
Information source: Inspire Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seasonal Allergic Rhinitis
Intervention: epinastine nasal spray, low concentration, low dose volume (Drug); placebo nasal spray (Drug); epinastine nasal spray, low concentration, high dose volume (Drug); epinastine nasal spray, high concentration, low dose volume (Drug); epinastine nasal spray, high concentration, high dose volume (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Inspire Pharmaceuticals Official(s) and/or principal investigator(s):
Donald Kellerman, PharmD, Study Director, Affiliation: Inspire Pharmaceuticals
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
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Primary outcome: Change in nasal symptom scores
Secondary outcome: Change in ocular symptom scores and quality of life scoresStandard safety assessments
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Allergy Asthma Research Institute, Waco, Texas 76712, United States
Diagnostics Research Group, San Antonio, Texas 78229, United States
Allergy & Asthma Research Center, P.A., San Antonio, Texas 78229, United States
Central Texas Health Research, New Braunfels, Texas 78130, United States
Lovelace Scientific Resources, Inc., Austin, Texas 78759, United States
Biogenics Research Institute, San Antonio, Texas 78229, United States
Kerrville Research Associates, P.A., Kerrville, Texas 78028, United States
Sylvana Research Associates, San Antonio, Texas 78229, United States
Allergy & Asthma Associates, Austin, Texas 78731, United States
Additional Information
Starting date: November 2007
Ending date: April 2008
Last updated: May 1, 2008
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