Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis

NCT ID: NCT00118703

Last Updated: 2017-08-21

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

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-01

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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Vasomotor Rhinitis Rhinitis, Vasomotor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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GW685698X

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must be outpatients.
* Diagnosis of VMR (vasomotor rhinitis).
* 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

Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Fresno, California, United States

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Irvine, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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Paramount, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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San Jose, California, United States

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Walnut Creek, California, United States

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Englewood, Colorado, United States

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Miami, Florida, United States

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Sarasota, Florida, United States

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Tallahassee, Florida, United States

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Vero Beach, Florida, United States

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Stockbridge, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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South Bend, Indiana, United States

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Shreveport, Louisiana, United States

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Bethesda, Maryland, United States

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Wheaton, Maryland, United States

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North Dartmouth, Massachusetts, United States

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Detroit, Michigan, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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Brick, New Jersey, United States

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Skillman, New Jersey, United States

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Ithaca, New York, United States

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Rochester, New York, United States

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Sylvania, Ohio, United States

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Blue Bell, Pennsylvania, United States

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Providence, Rhode Island, United States

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Chattanooga, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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South Burlington, Vermont, United States

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Winnipeg, Manitoba, Canada

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Hamilton, Ontario, Canada

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Ottawa, Ontario, Canada

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Trois-Rivières, Quebec, Canada

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Brno, , Czechia

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Pardubice, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Weinheim, Baden-Wurttemberg, Germany

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Nuremberg, Bavaria, Germany

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Wiesbaden, Hesse, Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Oslo, , Norway

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Oslo, , Norway

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Ponce, , Puerto Rico

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Bucharest, , Romania

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Iași, , Romania

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Countries

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United States Canada Czechia Germany Norway Puerto Rico Romania

Study Documents

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Document Type: Dataset Specification

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

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Document Type: Clinical Study Report

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

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Document Type: Annotated Case Report Form

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: Individual Participant Data Set

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: Statistical Analysis Plan

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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FFR30007

Identifier Type: -

Identifier Source: org_study_id

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