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Clinical Trials/NCT00407927
NCT00407927
Completed
Phase 2

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

Merck Sharp & Dohme LLC7 sites in 1 country571 target enrollmentDecember 2006
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ConditionsSeasonal Allergic Rhinitis
DrugsEpinastine Nasal Spray

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Seasonal Allergic Rhinitis
Sponsor
Merck Sharp & Dohme LLC
Enrollment
571
Locations
7
Primary Endpoint
Change in nasal symptom scores
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2006
End Date
March 2007
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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
  • •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

Outcomes

Primary Outcomes

Change in nasal symptom scores

Secondary Outcomes

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

Study Sites (7)

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