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Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)

NCT01753739 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 617

Last updated 2020-10-05

Study results available
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Summary

This study will examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to Mountain Cedar pollen for at least 2 years prior to the study.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Bepotastine besilate

Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days

DRUG

Placebo

Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Jon Williams, Ph.D. · Bausch & Lomb Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-02-28
Completion
2013-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01753739 on ClinicalTrials.gov