A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00116883
First received: June 30, 2005
Last updated: October 1, 2010
Last verified: October 2010
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Perennial Allergic Rhinitis |
Drug: GW685698X aqueous nasal spray |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 (PAR). |
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.
| Estimated Enrollment: | 90 |
| Study Start Date: | February 2005 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: GW685698X aqueous nasal spray
Other Name: GW685698X aqueous nasal spray
Eligibility| Ages Eligible for Study: | 2 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116883
Locations
| United States, Arkansas | |
| GSK Investigational Site | |
| Hot Springs, Arkansas, United States, 71913 | |
| GSK Investigational Site | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| GSK Investigational Site | |
| Long Beach, California, United States, 90806 | |
| United States, Florida | |
| GSK Investigational Site | |
| Jacksonville, Florida, United States, 32207 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| Lafayette, Louisiana, United States, 70503 | |
| United States, Missouri | |
| GSK Investigational Site | |
| Rolla, Missouri, United States, 65401 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Medford, Oregon, United States, 97504 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Orangeburg, South Carolina, United States, 29118 | |
| GSK Investigational Site | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Texas | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Richmond, Virginia, United States, 23298 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00116883 History of Changes |
| Other Study ID Numbers: | FFR100012 |
| Study First Received: | June 30, 2005 |
| Last Updated: | October 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
perennial allergic rhinitis intranasal corticosteroid GW685698X HPA axis function pediatric |
Additional relevant MeSH terms:
|
Rhinitis Rhinitis, Allergic, Perennial Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013