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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00564421
First received: November 27, 2007
Last updated: September 20, 2011
Last verified: September 2011

November 27, 2007
September 20, 2011
November 2007
April 2008   (final data collection date for primary outcome measure)
Change in nasal symptom scores [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Change in nasal symptom scores [ Time Frame: 14 days ]
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 ] [ Designated as safety issue: No ]
  • Standard safety assessments [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Change in ocular symptom scores and quality of life scores [ Time Frame: 14 days ]
  • Standard safety assessments [ Time Frame: 14 days ]
Not Provided
Not Provided
 
Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis
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 Blind (Subject, 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
  • Drug: placebo nasal spray
    2 sprays in each nostril, dosed twice a day
  • 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: 1
    Intervention: Drug: epinastine nasal spray, low concentration, low dose volume
  • Experimental: 2
    Intervention: Drug: epinastine nasal spray, low concentration, high dose volume
  • Experimental: 3
    Intervention: Drug: epinastine nasal spray, high concentration, low dose volume
  • Experimental: 4
    Intervention: Drug: epinastine nasal spray, high concentration, high dose volume
  • Placebo Comparator: 5
    Intervention: Drug: 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
April 2008
April 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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00564421
033-103, P08648
Not Provided
Amy Schaberg, BSN, Vice President Respiratory Clinical Research, Inspire Pharmaceuticals
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Donald Kellerman, PharmD Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2011

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