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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00564421

Enrollment

798

Registered

2007-11-28

Start date

2007-12-18

Completion date

2008-02-14

Last updated

2017-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

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

Interventions

DRUGepinastine nasal spray, low concentration, low dose volume

2 sprays in each nostril, dosed twice a day

OTHERplacebo nasal spray

2 sprays in each nostril, dosed twice a day

DRUGepinastine nasal spray, low concentration, high dose volume

2 sprays in each nostril, dosed twice a day

DRUGepinastine nasal spray, high concentration, low dose volume

2 sprays in each nostril, dosed twice a day

DRUGepinastine nasal spray, high concentration, high dose volume

2 sprays in each nostril, dosed twice a day

Sponsors

Merck Sharp & Dohme LLC

Lead SponsorINDUSTRY

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Change in nasal symptom scores	14 days

Secondary

Measure	Time frame
Change in ocular symptom scores and quality of life scores	14 days
Standard safety assessments	14 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026