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

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ClinicalTrials.gov Identifier: NCT00407927
Recruitment Status : Completed
First Posted : December 5, 2006
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Epinastine Nasal Spray Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 571 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : December 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever




Primary Outcome Measures :
  1. Change in nasal symptom scores

Secondary Outcome Measures :
  1. Change in non-nasal symptom scores and quality of life scores
  2. Standard safety assessments


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407927


Locations
United States, Texas
Allergy & Asthma Associates
Austin, Texas, United States, 78731
Lovelace Scientific Resources, Inc.
Austin, Texas, United States, 78759
Kerrville Research Associates
Kerrville, Texas, United States, 78028
Central Texas Health Research
New Braunfels, Texas, United States, 78130
Biogenics Research Institute
San Antonio, Texas, United States, 78229
Sylvana Research Associates
San Antonio, Texas, United States, 78229
Allergy Asthma Research Institute
Waco, Texas, United States, 76712
Sponsors and Collaborators
Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00407927     History of Changes
Other Study ID Numbers: 033-101
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Epinastine
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs