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

NCT ID: NCT00564421

Last Updated: 2017-03-24

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

PHASE3

Total Enrollment

798 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-18

Study Completion Date

2008-02-14

Brief Summary

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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

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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

Participants Investigators

Study Groups

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Epinastine low concentration:low dose volume

Group Type EXPERIMENTAL

epinastine nasal spray, low concentration, low dose volume

Intervention Type DRUG

2 sprays in each nostril, dosed twice a day

Epinastine low concentration:high dose volume

Group Type EXPERIMENTAL

epinastine nasal spray, low concentration, high dose volume

Intervention Type DRUG

2 sprays in each nostril, dosed twice a day

Epinastine high concentration:low dose volume

Group Type EXPERIMENTAL

epinastine nasal spray, high concentration, low dose volume

Intervention Type DRUG

2 sprays in each nostril, dosed twice a day

Epinastine high concentration:high dose volume

Group Type EXPERIMENTAL

epinastine nasal spray, high concentration, high dose volume

Intervention Type DRUG

2 sprays in each nostril, dosed twice a day

Placebo nasal spray

Group Type PLACEBO_COMPARATOR

placebo nasal spray

Intervention Type OTHER

2 sprays in each nostril, dosed twice a day

Interventions

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epinastine nasal spray, low concentration, low dose volume

2 sprays in each nostril, dosed twice a day

Intervention Type DRUG

placebo nasal spray

2 sprays in each nostril, dosed twice a day

Intervention Type OTHER

epinastine nasal spray, low concentration, high dose volume

2 sprays in each nostril, dosed twice a day

Intervention Type DRUG

epinastine nasal spray, high concentration, low dose volume

2 sprays in each nostril, dosed twice a day

Intervention Type DRUG

epinastine nasal spray, high concentration, high dose volume

2 sprays in each nostril, dosed twice a day

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald Kellerman, PharmD

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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033-103

Identifier Type: -

Identifier Source: secondary_id

P08648

Identifier Type: -

Identifier Source: org_study_id

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