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Seasonal Allergic Rhinitis In Pediatric Subjects

NCT ID: NCT00107757

Last Updated: 2016-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

576 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-11-30

Brief Summary

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The purpose of this study is to determine if the investigational drug is effective and safe in children with seasonal allergic rhinitis.

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Detailed Description

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Conditions

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Rhinitis, Allergic, Perennial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW685698X

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of seasonal allergic rhinitis.
* Adequate exposure to seasonal (Spring/Summer) allergen prevalent to the geographic area.

Exclusion Criteria

* Have significant concomitant medical conditions.
* Use of corticosteroids, other allergy meds during the study.
* Have abnormal ECG or laboratory abnormality.
Minimum Eligible Age

2 Years

Maximum 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

Scottsdale, Arizona, United States

Site Status

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Little Rock, Arkansas, United States

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Costa Mesa, California, United States

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Cudahy, California, United States

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Huntington Beach, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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Mission Viejo, California, United States

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Orange, California, United States

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Riverside, California, United States

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San Diego, California, United States

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Walnut Creek, California, United States

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Centennial, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Englewood, Colorado, United States

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Fort Collins, Colorado, United States

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Lakewood, Colorado, United States

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Miami, Florida, United States

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Tampa, Florida, United States

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Gainesville, Georgia, United States

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Lawrenceville, Georgia, United States

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Lilburn, Georgia, United States

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Stockbridge, Georgia, United States

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Woodstock, Georgia, United States

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Indianapolis, Indiana, United States

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Topeka, Kansas, United States

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Metairie, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Brockton, Massachusetts, United States

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North Andover, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Springfield, Massachusetts, United States

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Richland, Michigan, United States

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Ypsilanti, Michigan, United States

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Jackson, Mississippi, United States

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Kansas City, Missouri, United States

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Rolla, Missouri, United States

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Warrensburg, Missouri, United States

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Omaha, Nebraska, United States

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Hackensack, New Jersey, United States

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Ocean City, New Jersey, United States

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Ithaca, New York, United States

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Mineola, New York, United States

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Utica, New York, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Lake Oswego, Oregon, United States

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Altoona, Pennsylvania, United States

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Cranberry Township, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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El Paso, Texas, United States

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Greenfield, Wisconsin, United States

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Madison, Wisconsin, United States

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Countries

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United States

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: 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: Dataset Specification

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: Statistical Analysis Plan

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

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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FFR100010

Identifier Type: -

Identifier Source: org_study_id

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