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Safety Study of Entocort for Children With Crohn's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT01444092
First received: September 28, 2011
Last updated: November 16, 2016
Last verified: November 2016
September 28, 2011
November 16, 2016
November 2011
September 2014   (Final data collection date for primary outcome measure)
Adverse Event [ Time Frame: 12 weeks ]
Number of patients with at least one adverse event
Description of the safety profile in terms of adverse events, clinical laboratory evaluations, physical examinations, including evaluation of glucocorticosteroid-related side effects, hypothalamic-pituitary-adrenal axis, and vital signs. [ Time Frame: 12 weeks ]
Safety measures will be listed and summarized descriptively, with summaries including all subjects who received at least one dose of study treatment. No formal statistical analyses or hypothesis tests will be performed.
Complete list of historical versions of study NCT01444092 on ClinicalTrials.gov Archive Site
  • PCDAI [ Time Frame: Baseline to 8 weeks ]
    Paediatric Crohn's Disease Activity Index. Range from 0 (best) to 100 (worst).
  • IMPACT 3 [ Time Frame: Baseline to 8 weeks ]
    IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best).
IMPACT 3 Questionnaire for children with Inflammatory Bowel Disease [ Time Frame: 8 Weeks ]
Not Provided
Not Provided
 
Safety Study of Entocort for Children With 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
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
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn's Disease
Drug: Entocort
Entocort capsules, oral
Experimental: Entocort
Study Medication
Intervention: Drug: Entocort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
September 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   Italy,   Poland,   United States
 
 
NCT01444092
D9422C00001
Not Provided
Not Provided
Not Provided
Perrigo Company
Perrigo Company
Not Provided
Principal Investigator: Stanley Cohen, MD Children's Center for Digestive Healthcare, LLC, Atlanta, Georgia, USA and Emory University School of Medicine, Atlanta, Georgia, USA
Study Director: Stefan Eklund, MD AstraZeneca Pharmaceuticals, Mölndal, Sweden
Perrigo Company
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP