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Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber

NCT01222299 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2020-10-05

Study results available
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Summary

The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

bepotastine besilate nasal product - low dose

sterile nasal product

DRUG

bepotastine besilate nasal product - medium dose

sterile nasal product

DRUG

bepotastine besilate nasal product - high dose

sterile nasal product

DRUG

placebo comparator nasal product

sterile nasal product

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Tim McNamara, PharmD · ISTA Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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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 NCT01222299 on ClinicalTrials.gov