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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00564421
First Posted: November 28, 2007
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
November 27, 2007
November 28, 2007
March 24, 2017
December 18, 2007
February 14, 2008   (Final data collection date for primary outcome measure)
Change in nasal symptom scores [ Time Frame: 14 days ]
Same as current
Complete list of historical versions of study NCT00564421 on ClinicalTrials.gov Archive Site
  • Change in ocular symptom scores and quality of life scores [ Time Frame: 14 days ]
  • Standard safety assessments [ Time Frame: 14 days ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Seasonal Allergic Rhinitis
  • Drug: epinastine nasal spray, low concentration, low dose volume
    2 sprays in each nostril, dosed twice a day
  • Other: placebo nasal spray
    2 sprays in each nostril, dosed twice a day
    Other Name: Placebo
  • Drug: epinastine nasal spray, low concentration, high dose volume
    2 sprays in each nostril, dosed twice a day
  • Drug: epinastine nasal spray, high concentration, low dose volume
    2 sprays in each nostril, dosed twice a day
  • Drug: epinastine nasal spray, high concentration, high dose volume
    2 sprays in each nostril, dosed twice a day
  • Experimental: Epinastine low concentration:low dose volume
    Intervention: Drug: epinastine nasal spray, low concentration, low dose volume
  • Experimental: Epinastine low concentration:high dose volume
    Intervention: Drug: epinastine nasal spray, low concentration, high dose volume
  • Experimental: Epinastine high concentration:low dose volume
    Intervention: Drug: epinastine nasal spray, high concentration, low dose volume
  • Experimental: Epinastine high concentration:high dose volume
    Intervention: Drug: epinastine nasal spray, high concentration, high dose volume
  • Placebo Comparator: Placebo nasal spray
    Intervention: Other: placebo nasal spray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
798
February 14, 2008
February 14, 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00564421
P08648
033-103
Not Provided
Not Provided
Plan to Share IPD: Yes
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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Donald Kellerman, PharmD Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2017

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