Study Of Adults And Adolescents With Vasomotor Rhinitis

NCT ID: NCT00117325

Last Updated: 2018-03-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-11

Study Completion Date

2006-02-09

Brief Summary

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The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).

Detailed Description

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Conditions

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Rhinitis, Vasomotor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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GW685698X

GW685698X

Group Type EXPERIMENTAL

GW685698X

Intervention Type DRUG

Aqueous Nasal Spray 100mcg

Interventions

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GW685698X

Aqueous Nasal Spray 100mcg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must be outpatients.
* Diagnosis of VMR.
* Literate in English or native language.

Exclusion Criteria

* Significant concomitant medical condition.
* Use corticosteroids or other allergy medications during the study.
* Used tobacco products within the past year.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Beverly Hills, California, United States

Site Status

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Huntington Beach, California, United States

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Mission Viejo, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Santa Barbara, California, United States

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Colorado Springs, Colorado, United States

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Englewood, Colorado, United States

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Fort Collins, Colorado, United States

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Woodstock, Georgia, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Louisville, Kentucky, United States

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Covington, Louisiana, United States

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Shreveport, Louisiana, United States

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Bangor, Maine, United States

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Baltimore, Maryland, United States

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Rockville, Maryland, United States

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Novi, Michigan, United States

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Ypsilanti, Michigan, United States

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Minneapolis, Minnesota, United States

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Mount Laurel, New Jersey, United States

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Liverpool, New York, United States

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Rochester, New York, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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North Olmsted, Ohio, United States

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Lake Oswego, Oregon, United States

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Portland, Oregon, United States

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Easton, Pennsylvania, United States

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Palmyra, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Upland, Pennsylvania, United States

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Charleston, South Carolina, United States

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Orangeburg, South Carolina, United States

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Germantown, Tennessee, United States

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Knoxville, Tennessee, United States

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Salt Lake City, Utah, United States

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Kelowna, British Columbia, Canada

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Hamilton, Ontario, Canada

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Québec, , Canada

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Litoměřice, , Czechia

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Olomouc, , Czechia

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Tábor, , Czechia

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Kassel, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Schwerin, Mecklenburg-Vorpommern, Germany

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Geesthacht, Schleswig-Holstein, Germany

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Hamburg, , Germany

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Larvik, , Norway

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Nesttun, , Norway

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Bucharest, , Romania

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Deva, , Romania

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Countries

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United States Canada Czechia Germany Norway Romania

Study Documents

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Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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FFR30006

Identifier Type: -

Identifier Source: org_study_id

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