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NCT00407927 Clinical Trial

A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

Official title:
A Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Safety, Efficacy, and Tolerability Study of Two Doses of Epinastine Nasal Spray (0.05% and 0.1%) vs. Placebo in Subjects With Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00407927
Other study ID # 033-101
Secondary ID
Status Completed
Phase Phase 2
First received December 4, 2006
Last updated October 9, 2015
Start date December 2006
Est. completion date March 2007

Study information
Verified date October 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 571
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

- A documented history of seasonal allergic rhinitis to mountain cedar pollen

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Epinastine Nasal Spray

Locations
Country Name City State
United States Allergy & Asthma Associates Austin Texas
United States Lovelace Scientific Resources, Inc. Austin Texas
United States Kerrville Research Associates Kerrville Texas
United States Central Texas Health Research New Braunfels Texas
United States Biogenics Research Institute San Antonio Texas
United States Sylvana Research Associates San Antonio Texas
United States Allergy Asthma Research Institute Waco Texas

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

Country where clinical trial is conducted

United States, 

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