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Completed

NCT Number: NCT00564421

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

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

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epinastine nasal spray, low concentration, low dose volume

Drug

2 sprays in each nostril, dosed twice a day

Placebo nasal spray

Other

2 sprays in each nostril, dosed twice a day

Other names: Placebo

epinastine nasal spray, low concentration, high dose volume

Drug

2 sprays in each nostril, dosed twice a day

epinastine nasal spray, high concentration, low dose volume

Drug

2 sprays in each nostril, dosed twice a day

epinastine nasal spray, high concentration, high dose volume

Drug

2 sprays in each nostril, dosed twice a day

Primary outcomes

  1. Change in nasal symptom scores

    Time frame: 14 days

Secondary outcomes

  1. Change in ocular symptom scores and quality of life scores

    Time frame: 14 days

  2. Standard safety assessments

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 28, 2007
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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