Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)
NCT ID: NCT00305487
Last Updated: 2016-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
660 participants
INTERVENTIONAL
2006-03-31
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Ciclesonide nasal spray
Eligibility Criteria
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Inclusion Criteria
* General good health other than seasonal allergic rhinitis
* Positive standard skin prick test
Exclusion Criteria
* Participation in any investigational drug trial within the 30 days preceding the Screening Visit
* A known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation
* Plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period
* Plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days OR more than 3 days total during the treatment period
* Use of any prohibited concomitant medications
* Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit
* Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit
* Study participation by more than one patient from the same household
6 Years
11 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Altana Pharma/Nycomed
Birmingham, Alabama, United States
Altana Pharma/Nycomed
Hot Springs, Arkansas, United States
Altana Pharma/Nycomed
Costa Mesa, California, United States
Altana Pharma/Nycomed
Huntington Beach, California, United States
Altana Pharma/Nycomed
Long Beach, California, United States
Altana Pharma/Nycomed
Los Alamitos, California, United States
Altana Pharma/Nycomed
Mission Viejo, California, United States
Altana Pharma/Nycomed
Orange, California, United States
Altana Pharma/Nycomed
Roseville, California, United States
Altana Pharma/Nycomed
San Diego, California, United States
Altana Pharma/Nycomed
San Diego, California, United States
Altana Pharma/Nycomed
San Jose, California, United States
Altana Pharma/Nycomed
Stockton, California, United States
Altana Pharma/Nycomed
Colorado Springs, Colorado, United States
Altana Pharma/Nycomed
Denver, Colorado, United States
Altana Pharma/Nycomed
Englewood, Colorado, United States
Altana Pharma/Nycomed
Lakewood, CO, Colorado, United States
Altana Pharma/Nycomed
Atlanta, Georgia, United States
Altana Pharma/Nycomed
Gainesville, Georgia, United States
Altana Pharma/Nycomed
Savannah, Georgia, United States
Altana Pharma/Nycomed
Woodstock, GA, Georgia, United States
Altana Pharma/Nycomed
Normal, Illinois, United States
Altana Pharma/Nycomed
Indianapolis, Indiana, United States
Altana Pharma/Nycomed
Overland Park, Kansas, United States
Altana Pharma/Nycomed
Louisville, KY, Kentucky, United States
Altana Pharma/Nycomed
Metairie, Louisiana, United States
Altana Pharma/Nycomed
Shreveport, Louisiana, United States
Altana Pharma/Nycomed
Bethesda, Maryland, United States
Altana Pharma/Nycomed
North Dartmouth, Massachusetts, United States
Altana Pharma/Nycomed
Minneapolis, Minnesota, United States
Altana Pharma/Nycomed
Jefferson City, Missouri, United States
Altana Pharma/Nycomed
Rolla, Missouri, United States
Altana Pharma/Nycomed
St Louis, Missouri, United States
Altana Pharma/Nycomed
Lincoln, NE, Nebraska, United States
Altana Pharma/Nycomed
Papillion, Nebraska, United States
Altana Pharma/Nycomed
Brick, New Jersey, United States
Altana Pharma/Nycomed
Forked River, New Jersey, United States
Altana Pharma/Nycomed
Red Bank, New Jersey, United States
Altana Pharma/Nycomed
Skillman, New Jersey, United States
Altana Pharma/Nycomed
Warren Township, New Jersey, United States
Altana Pharma/Nycomed
Rochester, NY, New York, United States
Altana Pharma/Nycomed
Rockville Centre, New York, United States
Altana Pharma/Nycomed
Raleigh, North Carolina, United States
Altana Pharma/Nycomed
Cincinnati, Ohio, United States
Altana Pharma/Nycomed
Cincinnati, OH, Ohio, United States
Altana Pharma/Nycomed
Ashland, Oregon, United States
Altana Pharma/Nycomed
Lake Oswego, Oregon, United States
Altana Pharma/Nycomed
Medford, OR, Oregon, United States
Altana Pharma/Nycomed
Portland, Oregon, United States
Altana Pharma/Nycomed
Blue Bell, Pennsylvania, United States
Altana Pharma/Nycomed
Eerie, Pennsylvania, United States
Altana Pharma/Nycomed
Pittsburgh, Pennsylvania, United States
Altana Pharma/Nycomed
Pittsburgh, Pennsylvania, United States
Altana Pharma/Nycomed
Upland, Pennsylvania, United States
Altana Pharma/Nycomed
Charleston, South Carolina, United States
Altana Pharma/Nycomed
Charleston, SC, South Carolina, United States
Altana Pharma/Nycomed
Germantown, Tennessee, United States
Altana Pharma/Nycomed
Jackson, Tennessee, United States
Altana Pharma/Nycomed
Austin, Texas, United States
Altana Pharma/Nycomed
Austin, Texas, United States
Altana Pharma/Nycomed
Dallas, Texas, United States
Altana Pharma/Nycomed
El Paso, Texas, United States
Altana Pharma/Nycomed
Kerrville, Texas, United States
Altana Pharma/Nycomed
New Braunfels, Texas, United States
Altana Pharma/Nycomed
San Antonio, Texas, United States
Altana Pharma/Nycomed
Salt Lake City, Utah, United States
Altana Pharma/Nycomed
South Burlington, Vermont, United States
Altana Pharma/Nycomed
Burke, Virginia, United States
Altana Pharma/Nycomed
Charlottesville, Virginia, United States
Altana Pharma/Nycomed
Richmond, Virginia, United States
Altana Pharma/Nycomed
Milwaukee, Wisconsin, United States
Countries
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Related Links
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BY9010-M1-417-RDS-2007-04-27.pdf
Other Identifiers
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BY9010/M1-417
Identifier Type: -
Identifier Source: org_study_id