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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00116883

First received: June 30, 2005

Last updated: October 1, 2010

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2005

Last Updated Date

October 1, 2010

Start Date ^ICMJE

February 2005

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects

Original Primary Outcome Measures ^ICMJE

HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects.

Change History

Complete list of historical versions of study NCT00116883 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.

Original Secondary Outcome Measures ^ICMJE

Adverse events
Laboratory values
Nasal examination
Vital signs
ECG assessments
Pharmacokinetic assessments

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Double-blind, Parallel Group, Placebo Controlled, 6-week Study of the Effect of GW685698X Aqueous Nasal Spray 100mcg QD on the Hypothalamic Pituitary Adrenocortical (HPA) Axis in Children 2 to 11 Years of Age With Perennial Allergic Rhinitis (PAR).

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Perennial Allergic Rhinitis

Intervention ^ICMJE

Drug: GW685698X aqueous nasal spray

Other Name: GW685698X aqueous nasal spray

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2005

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

2 Years to 11 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00116883

Other Study ID Numbers ^ICMJE

FFR100012

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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