Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)
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
2 other identifiers
interventional
798
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2007
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2007
CompletedFirst Posted
Study publicly available on registry
November 28, 2007
CompletedStudy Start
First participant enrolled
December 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2008
CompletedMarch 24, 2017
March 1, 2017
2 months
November 27, 2007
March 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in nasal symptom scores
14 days
Secondary Outcomes (2)
Change in ocular symptom scores and quality of life scores
14 days
Standard safety assessments
14 days
Study Arms (5)
Epinastine low concentration:low dose volume
EXPERIMENTALEpinastine low concentration:high dose volume
EXPERIMENTALEpinastine high concentration:low dose volume
EXPERIMENTALEpinastine high concentration:high dose volume
EXPERIMENTALPlacebo nasal spray
PLACEBO COMPARATORInterventions
2 sprays in each nostril, dosed twice a day
2 sprays in each nostril, dosed twice a day
2 sprays in each nostril, dosed twice a day
2 sprays in each nostril, dosed twice a day
2 sprays in each nostril, dosed twice a day
Eligibility Criteria
You may qualify if:
- A documented history of seasonal allergic rhinitis to mountain cedar or other spring pollen
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Donald Kellerman, PharmD
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2007
First Posted
November 28, 2007
Study Start
December 18, 2007
Primary Completion
February 14, 2008
Study Completion
February 14, 2008
Last Updated
March 24, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php