Safety and Maintenance Study of Entocort for Children With Crohn's Disease
NCT ID: NCT01453946
Last Updated: 2022-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
55 participants
INTERVENTIONAL
2011-12-31
2014-02-28
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, taken orally, 6 mg daily.
Interventions
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Entocort
Entocort capsules, taken orally, 6 mg daily.
Eligibility Criteria
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Inclusion Criteria
* All subjects must weight \>= 15 kg at the time of enrollment.
* Subjects must have been diagnosed and treated for 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 and have a PCDAI \<= 10
Exclusion Criteria
* Subjects with evidence of active Crohn's disease (PCDAI \> 10) and/or stricturing, prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications.
* Subjects with morning cortisol level \<150 nmol/l (5.4 ug/dl) or DHEA-S below normal range for age and gender (NOTE: Subjects from the induction protocol with abnormal morning cortisol/DHEA-S levels at Visit 4, who otherwise meet the eligibility criteria, may be enrolled if the investigator decides that Entocort 6 mg is an appropriate therapy option.
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
Stefan Eklund, MD
Role: STUDY_DIRECTOR
AstraZeneca Pharmaceuticals, Mölndal, Sweden
Locations
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Research Site
Atlanta, Georgia, United States
Research Site
Oak Lawn, Illinois, United States
Research Site
Newton, Massachusetts, United States
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
Research Site
Nuremberg, , Germany
Research Site
Florence, , Italy
Research Site
Messina, , 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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D9422C00002
Identifier Type: -
Identifier Source: org_study_id
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