A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics
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).
1 other identifier
interventional
90
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2005
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedSeptember 15, 2016
September 1, 2016
5 months
June 30, 2005
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Significant concurrent medical conditions.
- Certain medications such as corticosteroids and allergy medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (12)
GSK Investigational Site
Hot Springs, Arkansas, 71913, United States
GSK Investigational Site
Little Rock, Arkansas, 72202, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Jacksonville, Florida, 32207, United States
GSK Investigational Site
West Palm Beach, Florida, 33409, United States
GSK Investigational Site
Lafayette, Louisiana, 70503, United States
GSK Investigational Site
Rolla, Missouri, 65401, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Richmond, Virginia, 23298, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 1, 2005
Study Start
February 1, 2005
Primary Completion
July 1, 2005
Study Completion
July 1, 2005
Last Updated
September 15, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.