Expired Study
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Hot Springs, Arkansas 71913


Purpose:

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.


Criteria:

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.


Study is Available At:


Original ID:

FFR100012


NCT ID:

NCT00116883


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

2 Years


Maximum Age:

11 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

GlaxoSmithKline


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

90


Enrollment Type:

Actual


Overall Contact Information

Official Name:GSK Clinical Trials
Study Director
GlaxoSmithKline

Study Dates

Start Date:February 2005
Completion Date:July 2005
Completion Type:Actual
Primary Completion Date:July 2005
Primary Completion Type:Actual
Verification Date:September 2016
Last Changed Date:September 13, 2016
First Received Date:June 30, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:GW685698X aqueous nasal spray
Arm Name:Arm 1

Study Arms

Study Arm Type:Experimental
Arm Name:Arm 1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:GlaxoSmithKline

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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