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

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

epinastine nasal spray, low concentration, low dose volume

placebo nasal spray

epinastine nasal spray, low concentration, high dose volume

epinastine nasal spray, high concentration, low dose volume

epinastine nasal spray, high concentration, high dose volume

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Epinastine low concentration:low dose volume

Epinastine low concentration:high dose volume

Epinastine high concentration:low dose volume

Epinastine high concentration:high dose volume

Placebo nasal spray

Arm Description

Outcomes

Primary Outcome Measures

Change in nasal symptom scores

Secondary Outcome Measures

Change in ocular symptom scores and quality of life scores

Standard safety assessments

Full Information

NCT ID

NCT00564421

First Posted

November 27, 2007

Last Updated

March 23, 2017

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00564421

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

December 18, 2007 (Actual)

Primary Completion Date

February 14, 2008 (Actual)

Study Completion Date

February 14, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

798 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Epinastine low concentration:low dose volume

Arm Type

Experimental

Arm Title

Epinastine low concentration:high dose volume

Arm Type

Experimental

Arm Title

Epinastine high concentration:low dose volume

Arm Type

Experimental

Arm Title

Epinastine high concentration:high dose volume

Arm Type

Experimental

Arm Title

Placebo nasal spray

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

epinastine nasal spray, low concentration, low dose volume

Intervention Description

2 sprays in each nostril, dosed twice a day

Intervention Type

Other

Intervention Name(s)

placebo nasal spray

Other Intervention Name(s)

Placebo

Intervention Description

2 sprays in each nostril, dosed twice a day

Intervention Type

Drug

Intervention Name(s)

epinastine nasal spray, low concentration, high dose volume

Intervention Description

2 sprays in each nostril, dosed twice a day

Intervention Type

Drug

Intervention Name(s)

epinastine nasal spray, high concentration, low dose volume

Intervention Description

2 sprays in each nostril, dosed twice a day

Intervention Type

Drug

Intervention Name(s)

epinastine nasal spray, high concentration, high dose volume

Intervention Description

2 sprays in each nostril, dosed twice a day

Primary Outcome Measure Information:

Title

Change in nasal symptom scores

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Change in ocular symptom scores and quality of life scores

Time Frame

14 days

Title

Standard safety assessments

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald Kellerman, PharmD

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Learn more about this trial

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

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