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Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00564421
Recruitment Status : Completed
First Posted : November 28, 2007
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: epinastine nasal spray, low concentration, low dose volume Other: 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  (Clinical Trial)
Actual Enrollment : 798 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : December 18, 2007
Primary Completion Date : February 14, 2008
Study Completion Date : February 14, 2008

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Epinastine low concentration:low dose volume Drug: epinastine nasal spray, low concentration, low dose volume
2 sprays in each nostril, dosed twice a day
Experimental: Epinastine low concentration:high dose volume Drug: epinastine nasal spray, low concentration, high dose volume
2 sprays in each nostril, dosed twice a day
Experimental: Epinastine high concentration:low dose volume Drug: epinastine nasal spray, high concentration, low dose volume
2 sprays in each nostril, dosed twice a day
Experimental: Epinastine high concentration:high dose volume Drug: epinastine nasal spray, high concentration, high dose volume
2 sprays in each nostril, dosed twice a day
Placebo Comparator: Placebo nasal spray Other: placebo nasal spray
2 sprays in each nostril, dosed twice a day
Other Name: Placebo



Primary Outcome Measures :
  1. Change in nasal symptom scores [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Change in ocular symptom scores and quality of life scores [ Time Frame: 14 days ]
  2. Standard safety assessments [ Time Frame: 14 days ]


Information from the National Library of Medicine

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

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): NCT00564421


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Donald Kellerman, PharmD Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00564421     History of Changes
Other Study ID Numbers: P08648
033-103
First Posted: November 28, 2007    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


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