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

NCT ID: NCT01222299

Last Updated: 2020-10-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1 - Low Dose

bepotastine besilate nasal product - low dose

Group Type EXPERIMENTAL

bepotastine besilate nasal product - low dose

Intervention Type DRUG

sterile nasal product

Arm 2 - Medium Dose

bepotastine besilate nasal product - medium dose

Group Type EXPERIMENTAL

bepotastine besilate nasal product - medium dose

Intervention Type DRUG

sterile nasal product

Arm 3 - High Dose

bepotastine besilate nasal product - high dose

Group Type EXPERIMENTAL

bepotastine besilate nasal product - high dose

Intervention Type DRUG

sterile nasal product

Arm 4 - Placebo

placebo comparator nasal product

Group Type PLACEBO_COMPARATOR

placebo comparator nasal product

Intervention Type DRUG

sterile nasal product

Interventions

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bepotastine besilate nasal product - low dose

sterile nasal product

Intervention Type DRUG

bepotastine besilate nasal product - medium dose

sterile nasal product

Intervention Type DRUG

bepotastine besilate nasal product - high dose

sterile nasal product

Intervention Type DRUG

placebo comparator nasal product

sterile nasal product

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen

Exclusion Criteria

* No active respiratory tract infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim McNamara, PharmD

Role: STUDY_DIRECTOR

ISTA Pharmaceuticals, Inc.

Locations

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ISTA Pharmaceuticals, Inc.

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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S00032

Identifier Type: -

Identifier Source: org_study_id

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