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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
ClinicalTrials.gov Identifier:
NCT00564421
First received: November 27, 2007
Last updated: September 20, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Seasonal Allergic Rhinitis
 Drug: epinastine nasal spray, low concentration, low dose volume
Drug: placebo nasal spray
Drug: epinastine nasal spray, low concentration, high dose volume
Drug: epinastine nasal spray, high concentration, low dose volume
Drug: epinastine nasal spray, high concentration, high dose volume
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 798
Study Start Date: November 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: epinastine nasal spray, low concentration, low dose volume
2 sprays in each nostril, dosed twice a day
Experimental: 2 Drug: epinastine nasal spray, low concentration, high dose volume
2 sprays in each nostril, dosed twice a day
Experimental: 3 Drug: epinastine nasal spray, high concentration, low dose volume
2 sprays in each nostril, dosed twice a day
Experimental: 4 Drug: epinastine nasal spray, high concentration, high dose volume
2 sprays in each nostril, dosed twice a day
Placebo Comparator: 5 Drug: placebo nasal spray
2 sprays in each nostril, dosed twice a day

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564421

Locations
United States, Texas
Allergy & Asthma Associates
Austin, Texas, United States, 78731
Lovelace Scientific Resources, Inc.
Austin, Texas, United States, 78759
Kerrville Research Associates, P.A.
Kerrville, Texas, United States, 78028
Central Texas Health Research
New Braunfels, Texas, United States, 78130
Diagnostics Research Group
San Antonio, Texas, United States, 78229
Allergy & Asthma Research Center, P.A.
San Antonio, Texas, United States, 78229
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
Investigators
Study Director: Donald Kellerman, PharmD Merck
  More Information

No publications provided

Responsible Party: Amy Schaberg, BSN, Vice President Respiratory Clinical Research, Inspire Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00564421     History of Changes
Other Study ID Numbers: 033-103, P08648
Study First Received: November 27, 2007
Last Updated: September 20, 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 May 19, 2013