A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.
A Multicenter, Open label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Entocort capsules, taken orally, 6 mg daily.
Research Site
Atlanta, Georgia, United States
Research Site
Oak Lawn, Illinois, United States
Research Site
Newton, Massachusetts, United States
Adverse Event
Any kind of adverse event
Time frame: 16 weeks
PCDAI
Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity)
Time frame: 12 weeks
IMPACT 3
IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE
Time frame: 12 weeks
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Research Site
Saint Paul, Minnesota, United States
Research Site
Mays Landing, New Jersey, United States
Research Site
Buffalo, New York, United States
Research Site
Houston, Texas, United States
Research Site
Halifax, Nova Scotia, Canada
Research Site
London, Ontario, Canada
Research Site
München, Germany
...and 9 more locations