Safety Study of Entocort for Children With Crohn's Disease



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:5 - 17
Updated:5/5/2014
Start Date:November 2011
End Date:August 2014
Contact:AstraZeneca Clinical Study Information
Email:ClinicalTrialTransparency@astrazeneca.com
Phone:800-236-9933

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A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

A Safety Study using 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 for
the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Inclusion Criteria:

- All male and female subjects must be aged 5 to 17, inclusive, and must not have
reached their 18th birthday by the estimated final office visit.

- Subject must be diagnosed with active Crohn's disease of the ileum and/or ascending
colon confirmed by endoscopic and/or radiographic evidence, and/or evidence of
mucosal erosions and/or histology.

- Subjects with mild to moderate Crohn's disease.

- All subjects must have a stool analysis negative for Clostridium difficile toxin,
Yersinia enterolytica, Campylobacter jejuni, Salmonella, Shigella, within the 30 days
prior to visit 1.

- All subjects must have had laboratory assessments within 7 days prior to visit 1.

- All subjects must weigh >= 15 kg at time of enrollment

Exclusion Criteria:

- Subjects who have had any previous intestinal resection proximal to and including the
ascending colon

- Subjects with evidence of severe active Crohn's disease and/or, stricturing and
prestenotic dilatation, clinical evidence of obstruction, perirectal abscess,
perirectal disease with active draining fistulas, perforation, or any septic
complications

- Subjects who do not have a negative stool analysis, within the 30 days prior to visit
1

- Subjects who have been screened/or enrolled in this study previously within the last
30 days

- Subjects with morning cortisol level <150 nmol/l (5.4 ug/dl) or DHEA-S below normal
range for age and gender
We found this trial at
17
sites
453
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Morristown, NJ
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436
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Atlanta, GA
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Aurora, CO
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492
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Birmingham, AL
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643
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Boston, MA
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Buffalo, NY
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274
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Chicago, IL
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Greenville, North Carolina 27834
429
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Greenville, NC
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991
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Houston, TX
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668
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Jacksonville, FL
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1972
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Los Angeles, CA
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442
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Mays Landing, NJ
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335
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Milwaukee, WI
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331
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Nashville, TN
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798
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New Orleans, LA
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275
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Oak Lawn, IL
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622
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St. Paul, MN
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