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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00407927
First received: December 4, 2006
Last updated: October 15, 2014
Last verified: October 2014

December 4, 2006
October 15, 2014
December 2006
March 2007   (final data collection date for primary outcome measure)
Change in nasal symptom scores
Same as current
Complete list of historical versions of study NCT00407927 on ClinicalTrials.gov Archive Site
  • Change in non-nasal symptom scores and quality of life scores
  • Standard safety assessments
Same as current
Not Provided
Not Provided
 
A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Seasonal Allergic Rhinitis
Drug: Epinastine Nasal Spray
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
571
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
12 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00407927
033-101
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2014

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