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Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis

NCT ID: NCT01277341

Last Updated: 2020-10-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

601 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-05-31

Brief Summary

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This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.

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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2% Twice a day

Bepotastine Besilate Nasal Spray 2% Twice a day

Group Type EXPERIMENTAL

Bepotastine Besilate Nasal Spray 2% Twice a day

Intervention Type DRUG

nasal spray

3% Twice a day

Bepotastine Besilate Nasal Spray 3% Twice a day

Group Type EXPERIMENTAL

Bepotastine Besilate Nasal Spray 3% Twice a day

Intervention Type DRUG

nasal spray

4% Twice a day

Bepotastine Besilate Nasal Spray 4% Twice a day

Group Type EXPERIMENTAL

Bepotastine Besilate Nasal Spray 4% Twice a day

Intervention Type DRUG

nasal spray

Placebo

Placebo nasal spray

Group Type PLACEBO_COMPARATOR

Placebo Nasal Spray

Intervention Type DRUG

nasal spray

Interventions

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Bepotastine Besilate Nasal Spray 2% Twice a day

nasal spray

Intervention Type DRUG

Bepotastine Besilate Nasal Spray 3% Twice a day

nasal spray

Intervention Type DRUG

Bepotastine Besilate Nasal Spray 4% Twice a day

nasal spray

Intervention Type DRUG

Placebo Nasal Spray

nasal spray

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female at least 12 years of age with a history of mountain cedar allergy

Exclusion Criteria

* No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
Minimum Eligible Age

12 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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S00082

Identifier Type: -

Identifier Source: org_study_id