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Safety Study of Entocort for Children With Crohn's Disease

This study has been completed.
Information provided by (Responsible Party):
Perrigo Company Identifier:
First received: September 28, 2011
Last updated: November 16, 2016
Last verified: November 2016
A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease

Condition Intervention Phase
Crohn's Disease Drug: Entocort Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Perrigo Company:

Primary Outcome Measures:
  • Adverse Event [ Time Frame: 12 weeks ]
    Number of patients with at least one adverse event

Secondary Outcome Measures:
  • 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).

Enrollment: 123
Study Start Date: November 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Entocort
Study Medication
Drug: Entocort
Entocort capsules, oral

Detailed Description:
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

Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01444092

  Show 24 Study Locations
Sponsors and Collaborators
Perrigo Company
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
  More Information

Additional Information:
Responsible Party: Perrigo Company Identifier: NCT01444092     History of Changes
Other Study ID Numbers: D9422C00001
Study First Received: September 28, 2011
Results First Received: May 19, 2015
Last Updated: November 16, 2016

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 21, 2017