Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis - Tabular View

Tracking Information

First Received Date ^ICMJE

November 27, 2007

Last Updated Date

May 1, 2008

Start Date ^ICMJE

November 2007

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in nasal symptom scores [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in nasal symptom scores [ Time Frame: 14 days ]

Change History

Complete list of historical versions of study NCT00564421 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in ocular symptom scores and quality of life scores [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Standard safety assessments [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment

Condition ^ICMJE

Seasonal Allergic Rhinitis

Intervention ^ICMJE

Drug: epinastine nasal spray, low concentration, low dose volume
Drug: placebo nasal spray
Drug: epinastine nasal spray, low concentration, high dose volume
Drug: epinastine nasal spray, high concentration, low dose volume
Drug: epinastine nasal spray, high concentration, high dose volume

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

798

Completion Date

April 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00564421

Responsible Party

Amy Schaberg, BSN, Vice President Respiratory Clinical Research, Inspire Pharmaceuticals

Study ID Numbers ^ICMJE

033-103

Study Sponsor ^ICMJE

Inspire Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Donald Kellerman, PharmD

Inspire Pharmaceuticals

Information Provided By

Inspire Pharmaceuticals

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP