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Safety Study of Olopatadine Nasal Spray

NCT ID: NCT00578331

Last Updated: 2017-10-31

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

PHASE3

Total Enrollment

890 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-01-31

Brief Summary

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The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.

Detailed Description

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Conditions

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Perennial Allergic Rhinitis

Keywords

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rhinitis perennial allergic rhinitis allergic rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Olopatadine 0.6% Nasal Spray

2 sprays each nostril twice daily

Group Type EXPERIMENTAL

Olopatadine 0.6% nasal spray

Intervention Type DRUG

2 sprays each nostril twice daily

Placebo Nasal Spray

2 sprays each nostril twice daily

Group Type PLACEBO_COMPARATOR

Placebo Nasal Spray

Intervention Type DRUG

2 sprays each nostril twice daily

Interventions

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Olopatadine 0.6% nasal spray

2 sprays each nostril twice daily

Intervention Type DRUG

Placebo Nasal Spray

2 sprays each nostril twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older

Exclusion Criteria

* Age 11 years and younger
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret Drake

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Waco

Waco, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-05-69

Identifier Type: -

Identifier Source: org_study_id