Safety Study of Entocort for Children With Crohn's Disease
NCT ID: NCT01444092
Last Updated: 2022-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
123 participants
INTERVENTIONAL
2011-11-30
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Entocort
Study Medication
Entocort
Entocort capsules, oral
Interventions
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Entocort
Entocort capsules, oral
Eligibility Criteria
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Inclusion Criteria
* 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 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
5 Years
17 Years
ALL
No
Sponsors
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Padagis LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Stanley Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Center for Digestive Healthcare, LLC, Atlanta, Georgia, USA and Emory University School of Medicine, Atlanta, Georgia, USA
Stefan Eklund, MD
Role: STUDY_DIRECTOR
AstraZeneca Pharmaceuticals, Mölndal, Sweden
Locations
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Research Site
Aurora, Colorado, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Oak Lawn, Illinois, United States
Research Site
Boston, Massachusetts, United States
Research Site
Saint Paul, Minnesota, United States
Research Site
Mays Landing, New Jersey, United States
Research Site
Morristown, New Jersey, United States
Research Site
Buffalo, New York, United States
Research Site
Greenville, North Carolina, United States
Research Site
Nashville, Tennessee, United States
Research Site
Halifax, Nova Scotia, Canada
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
München, , Germany
Research Site
Florence, , Italy
Research Site
Messina, , Italy
Research Site
Napoli, , Italy
Research Site
Roma, , Italy
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Rzeszów, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Countries
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References
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Cohen SA, Aloi M, Arumugam R, Baker R, Bax K, Kierkus J, Koletzko S, Lionetti P, Persson T, Eklund S. Enteric-coated budesonide for the induction and maintenance of remission of Crohn's disease in children. Curr Med Res Opin. 2017 Jul;33(7):1261-1268. doi: 10.1080/03007995.2017.1313213. Epub 2017 Apr 19.
Related Links
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Other Identifiers
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D9422C00001
Identifier Type: -
Identifier Source: org_study_id
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