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Seasonal Allergic Rhinitis In Pediatric Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00107757
First received: April 7, 2005
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
The purpose of this study is to determine if the investigational drug is effective and safe in children with seasonal allergic rhinitis.

Condition Intervention Phase
Rhinitis, Allergic, Perennial
Drug: GW685698X
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Improvement in daily, reflective total nasal symptom scores after 2 weeks of treatment in subjects ages 6 to <12 years.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 576
Study Start Date: March 2005
Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   2 Years to 12 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosis of seasonal allergic rhinitis.
  • Adequate exposure to seasonal (Spring/Summer) allergen prevalent to the geographic area.

Exclusion criteria:

  • Have significant concomitant medical conditions.
  • Use of corticosteroids, other allergy meds during the study.
  • Have abnormal ECG or laboratory abnormality.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107757

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72202
United States, California
GSK Investigational Site
Costa Mesa, California, United States, 92626
GSK Investigational Site
Cudahy, California, United States, 90201
GSK Investigational Site
Huntington Beach, California, United States, 92647
GSK Investigational Site
Long Beach, California, United States, 90806
GSK Investigational Site
Long Beach, California, United States, 90808
GSK Investigational Site
Mission Viejo, California, United States, 92691
GSK Investigational Site
Orange, California, United States, 92868
GSK Investigational Site
Riverside, California, United States, 92506
GSK Investigational Site
San Diego, California, United States, 92123
GSK Investigational Site
Walnut Creek, California, United States, 94598
United States, Colorado
GSK Investigational Site
Centennial, Colorado, United States, 80112
GSK Investigational Site
Denver, Colorado, United States, 80206
GSK Investigational Site
Denver, Colorado, United States, 80230
GSK Investigational Site
Englewood, Colorado, United States, 80112
GSK Investigational Site
Fort Collins, Colorado, United States, 80526
GSK Investigational Site
Lakewood, Colorado, United States, 80401
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33176
GSK Investigational Site
Tampa, Florida, United States, 33613
United States, Georgia
GSK Investigational Site
Gainesville, Georgia, United States, 30501
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
GSK Investigational Site
Lilburn, Georgia, United States, 30047
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
GSK Investigational Site
Woodstock, Georgia, United States, 30188
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
United States, Kansas
GSK Investigational Site
Topeka, Kansas, United States, 66606
United States, Louisiana
GSK Investigational Site
Metairie, Louisiana, United States, 70006
GSK Investigational Site
Shreveport, Louisiana, United States, 71105
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21236
GSK Investigational Site
Bethesda, Maryland, United States, 20814
United States, Massachusetts
GSK Investigational Site
Brockton, Massachusetts, United States, 02301
GSK Investigational Site
North Andover, Massachusetts, United States, 01845
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
GSK Investigational Site
Springfield, Massachusetts, United States, 01107
United States, Michigan
GSK Investigational Site
Richland, Michigan, United States, 49083
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39202
United States, Missouri
GSK Investigational Site
Kansas City, Missouri, United States, 64108
GSK Investigational Site
Rolla, Missouri, United States, 65401
GSK Investigational Site
Warrensburg, Missouri, United States, 64093
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68130
United States, New Jersey
GSK Investigational Site
Hackensack, New Jersey, United States, 07601
GSK Investigational Site
Ocean, New Jersey, United States, 07712
United States, New York
GSK Investigational Site
Ithaca, New York, United States, 14850
GSK Investigational Site
Mineola, New York, United States, 11501
GSK Investigational Site
Utica, New York, United States, 13502
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27710
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
GSK Investigational Site
Lake Oswego, Oregon, United States, 97035
United States, Pennsylvania
GSK Investigational Site
Altoona, Pennsylvania, United States, 16601
GSK Investigational Site
Cranberry Township, Pennsylvania, United States, 16066
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29406
United States, Tennessee
GSK Investigational Site
Knoxville, Tennessee, United States, 37922
GSK Investigational Site
Nashville, Tennessee, United States, 37203-1424
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75231
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
El Paso, Texas, United States, 79902
GSK Investigational Site
El Paso, Texas, United States, 79925
United States, Wisconsin
GSK Investigational Site
Greenfield, Wisconsin, United States, 53228
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: FFR100010
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: FFR100010
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: FFR100010
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: FFR100010
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: FFR100010
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: FFR100010
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: FFR100010
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00107757     History of Changes
Other Study ID Numbers: FFR100010 
Study First Received: April 7, 2005
Last Updated: September 13, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
pediatric
Seasonal allergic rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
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 September 30, 2016