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Safety Study of Entocort for Children With Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01444092
Recruitment Status : Completed
First Posted : September 30, 2011
Results First Posted : August 11, 2016
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
Padagis LLC

Study Description
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Brief Summary:
A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Entocort Phase 3

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: N/A
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
Study Start Date : November 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Budesonide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Entocort
Study Medication
 Drug: Entocort
Entocort capsules, oral


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


Secondary Outcome Measures :
  1. PCDAI [ Time Frame: Baseline to 8 weeks ]
    Paediatric Crohn's Disease Activity Index. Range from 0 (best) to 100 (worst).

  2. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444092


Locations
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United States, Colorado
Research Site
Aurora, Colorado, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
Research Site
Oak Lawn, Illinois, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, Minnesota
Research Site
Saint Paul, Minnesota, United States
United States, New Jersey
Research Site
Mays Landing, New Jersey, United States
Research Site
Morristown, New Jersey, United States
United States, New York
Research Site
Buffalo, New York, United States
United States, North Carolina
Research Site
Greenville, North Carolina, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Germany
Research Site
München, Germany
Italy
Research Site
Firenze, Italy
Research Site
Messina, Italy
Research Site
Napoli, Italy
Research Site
Roma, Italy
Poland
Research Site
Kraków, Poland
Research Site
Rzeszów, Poland
Research Site
Warszawa, Poland
Research Site
Wrocław, Poland
Research Site
Łódź, Poland
Sponsors and Collaborators
Padagis LLC
Investigators
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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
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Padagis LLC
ClinicalTrials.gov Identifier: NCT01444092    
Other Study ID Numbers: D9422C00001
First Posted: September 30, 2011    Key Record Dates
Results First Posted: August 11, 2016
Last Update Posted: January 6, 2022
Last Verified: January 2022
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists