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NCT00564421 Clinical Trial

Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00564421
Other study ID # P08648
Secondary ID 033-103
Status Completed
Phase Phase 3
First received November 27, 2007
Last updated March 23, 2017
Start date December 18, 2007
Est. completion date February 14, 2008

Study information
Verified date March 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 798
Est. completion date February 14, 2008
Est. primary completion date February 14, 2008
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• epinastine nasal spray, low concentration, low dose volume
2 sprays in each nostril, dosed twice a day
Other:
• placebo nasal spray
2 sprays in each nostril, dosed twice a day
Drug:
• epinastine nasal spray, low concentration, high dose volume
2 sprays in each nostril, dosed twice a day
• epinastine nasal spray, high concentration, low dose volume
2 sprays in each nostril, dosed twice a day
• epinastine nasal spray, high concentration, high dose volume
2 sprays in each nostril, dosed twice a day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary Change in nasal symptom scores 14 days
Secondary Change in ocular symptom scores and quality of life scores 14 days
Secondary Standard safety assessments 14 days
See also
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