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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Epinastine Nasal Spray
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

  • Allergy & Asthma Associates
  • Lovelace Scientific Resources, Inc.
  • Kerrville Research Associates
  • Central Texas Health Research
  • Biogenics Research Institute
  • Sylvana Research Associates
  • Allergy Asthma Research Institute

Outcomes

Primary Outcome Measures

Change in nasal symptom scores

Secondary Outcome Measures

Change in non-nasal symptom scores and quality of life scores
Standard safety assessments

Full Information

First Posted
December 4, 2006
Last Updated
October 9, 2015
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00407927
Brief Title
A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis
Official Title
A Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Safety, Efficacy, and Tolerability Study of Two Doses of Epinastine Nasal Spray (0.05% and 0.1%) vs. Placebo in Subjects With Seasonal Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (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 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.

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 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
571 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Epinastine Nasal Spray
Primary Outcome Measure Information:
Title
Change in nasal symptom scores
Secondary Outcome Measure Information:
Title
Change in non-nasal symptom scores and quality of life scores
Title
Standard safety assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Eligibility Criteria
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
Facility Information:
Facility Name
Allergy & Asthma Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Kerrville Research Associates
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Biogenics Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sylvana Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Allergy Asthma Research Institute
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States

12. IPD Sharing Statement

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

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