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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

571 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Epinastine Nasal Spray

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No