Seasonal Allergic Rhinitis In Pediatric Subjects
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 2 Weeks in Pediatric Subjects Ages 2 to <12 Years With Seasonal Allergic Rhinitis (SAR)
1 other identifier
interventional
576
1 country
65
Brief Summary
The purpose of this study is to determine if the investigational drug is effective and safe in children with seasonal allergic rhinitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2005
Shorter than P25 for phase_3
65 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
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 7, 2005
CompletedFirst Posted
Study publicly available on registry
April 8, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedSeptember 15, 2016
September 1, 2016
April 7, 2005
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in daily, reflective total nasal symptom scores after 2 weeks of treatment in subjects ages 6 to <12 years.
Secondary Outcomes (1)
Improvement in AM, pre-dose, instantaneous total nasal symptom scores after 2 weeks of treatment, overall evaluation of response to therapy after 2 weeks of treatment for subjects ages 6 to <12 years.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of seasonal allergic rhinitis.
- Adequate exposure to seasonal (Spring/Summer) allergen prevalent to the geographic area.
You may not qualify if:
- Have significant concomitant medical conditions.
- Use of corticosteroids, other allergy meds during the study.
- Have abnormal ECG or laboratory abnormality.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (65)
GSK Investigational Site
Scottsdale, Arizona, 85251, United States
GSK Investigational Site
Little Rock, Arkansas, 72202, United States
GSK Investigational Site
Costa Mesa, California, 92626, United States
GSK Investigational Site
Cudahy, California, 90201, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
Centennial, Colorado, 80112, United States
GSK Investigational Site
Denver, Colorado, 80206, United States
GSK Investigational Site
Denver, Colorado, 80230, United States
GSK Investigational Site
Englewood, Colorado, 80112, United States
GSK Investigational Site
Fort Collins, Colorado, 80526, United States
GSK Investigational Site
Lakewood, Colorado, 80401, United States
GSK Investigational Site
Miami, Florida, 33176, United States
GSK Investigational Site
Tampa, Florida, 33613, United States
GSK Investigational Site
Gainesville, Georgia, 30501, United States
GSK Investigational Site
Lawrenceville, Georgia, 30045, United States
GSK Investigational Site
Lilburn, Georgia, 30047, United States
GSK Investigational Site
Stockbridge, Georgia, 30281, United States
GSK Investigational Site
Woodstock, Georgia, 30188, United States
GSK Investigational Site
Indianapolis, Indiana, 46208, United States
GSK Investigational Site
Topeka, Kansas, 66606, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Shreveport, Louisiana, 71105, United States
GSK Investigational Site
Baltimore, Maryland, 21236, United States
GSK Investigational Site
Bethesda, Maryland, 20814, United States
GSK Investigational Site
Brockton, Massachusetts, 02301, United States
GSK Investigational Site
North Andover, Massachusetts, 01845, United States
GSK Investigational Site
North Dartmouth, Massachusetts, 02747, United States
GSK Investigational Site
Springfield, Massachusetts, 01107, United States
GSK Investigational Site
Richland, Michigan, 49083, United States
GSK Investigational Site
Ypsilanti, Michigan, 48197, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
Kansas City, Missouri, 64108, United States
GSK Investigational Site
Rolla, Missouri, 65401, United States
GSK Investigational Site
Warrensburg, Missouri, 64093, United States
GSK Investigational Site
Omaha, Nebraska, 68130, United States
GSK Investigational Site
Hackensack, New Jersey, 07601, United States
GSK Investigational Site
Ocean City, New Jersey, 07712, United States
GSK Investigational Site
Ithaca, New York, 14850, United States
GSK Investigational Site
Mineola, New York, 11501, United States
GSK Investigational Site
Utica, New York, 13502, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Lake Oswego, Oregon, 97035, United States
GSK Investigational Site
Altoona, Pennsylvania, 16601, United States
GSK Investigational Site
Cranberry Township, Pennsylvania, 16066, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Charleston, South Carolina, 29406, United States
GSK Investigational Site
Knoxville, Tennessee, 37922, United States
GSK Investigational Site
Nashville, Tennessee, 37203-1424, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
El Paso, Texas, 79902, United States
GSK Investigational Site
El Paso, Texas, 79925, United States
GSK Investigational Site
Greenfield, Wisconsin, 53228, United States
GSK Investigational Site
Madison, Wisconsin, 53792, 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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2005
First Posted
April 8, 2005
Study Start
March 1, 2005
Study Completion
November 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.