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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00407927
First received: December 4, 2006
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Seasonal Allergic Rhinitis
 Drug: Epinastine Nasal Spray
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change in nasal symptom scores

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

Estimated Enrollment: 580
Study Start Date: December 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Sylvana Research Associates
San Antonio, Texas, United States, 78229
Biogenics Research Institute
San Antonio, Texas, United States, 78229
Allergy Asthma Research Institute
Waco, Texas, United States, 76712
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Inspire Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00407927     History of Changes
Other Study ID Numbers: 033-101
Study First Received: December 4, 2006
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 17, 2013