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

March 23, 2017 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

798

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo nasal spray
Other: placebo nasal spray
2 sprays in each nostril, dosed twice a day
Other Names:
  • Placebo
Experimental: Epinastine low concentration:low dose volume
Drug: epinastine nasal spray, low concentration, low dose volume
2 sprays in each nostril, dosed twice a day
Experimental: Epinastine low concentration:high dose volume
Drug: epinastine nasal spray, low concentration, high dose volume
2 sprays in each nostril, dosed twice a day
Experimental: Epinastine high concentration:low dose volume
Drug: epinastine nasal spray, high concentration, low dose volume
2 sprays in each nostril, dosed twice a day
Experimental: Epinastine high concentration:high dose volume
Drug: epinastine nasal spray, high concentration, high dose volume
2 sprays in each nostril, dosed twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in nasal symptom scores
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in ocular symptom scores and quality of life scores
Time Frame: 14 days
14 days
Standard safety assessments
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Donald Kellerman, PharmD, Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2007

Primary Completion (Actual)

February 14, 2008

Study Completion (Actual)

February 14, 2008

Study Registration Dates

First Submitted

November 27, 2007

First Submitted That Met QC Criteria

November 27, 2007

First Posted (Estimate)

November 28, 2007

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P08648
  • 033-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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