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

NCT00564421 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 798

Last updated 2017-03-24

No results posted yet for this study

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

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

epinastine nasal spray, low concentration, low dose volume

2 sprays in each nostril, dosed twice a day

OTHER

placebo nasal spray

2 sprays in each nostril, dosed twice a day

DRUG

epinastine nasal spray, low concentration, high dose volume

2 sprays in each nostril, dosed twice a day

DRUG

epinastine nasal spray, high concentration, low dose volume

2 sprays in each nostril, dosed twice a day

DRUG

epinastine nasal spray, high concentration, high dose volume

2 sprays in each nostril, dosed twice a day

Sponsors & Collaborators

Principal Investigators

  • Donald Kellerman, PharmD · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-18
Primary Completion
2008-02-14
Completion
2008-02-14

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00564421 on ClinicalTrials.gov