A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-07-31

Brief Summary

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The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound GW685698X compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in children 2 to 11 years of age with perennial 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

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

GW685698X aqueous nasal spray

Intervention Type DRUG

Interventions

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GW685698X aqueous nasal spray

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis and history of perennial allergic rhinitis.
* Must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours.
* Must comply with all study procedures and be literate.

Exclusion Criteria

* Significant concurrent medical conditions.
* Certain medications such as corticosteroids and allergy medications.

Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Hot Springs, Arkansas, United States

Site Status

GSK Investigational Site

Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

Long Beach, California, United States

Site Status

GSK Investigational Site

Jacksonville, Florida, United States

Site Status

GSK Investigational Site

West Palm Beach, Florida, United States

Site Status

GSK Investigational Site

Lafayette, Louisiana, United States

Site Status

GSK Investigational Site

Rolla, Missouri, United States

Site Status

GSK Investigational Site

Medford, Oregon, United States

Site Status

GSK Investigational Site

Orangeburg, South Carolina, United States

Site Status

GSK Investigational Site

Spartanburg, South Carolina, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

Richmond, Virginia, United States

Site Status

Countries

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United States

Study Documents

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