Safety Study of Entocort for Children With Crohn's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01444092
First received: September 28, 2011
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • IMPACT 3 Questionnaire for children with Inflammatory Bowel Disease [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
  • Disease activity on trial population before and after treatment through Paediatric Crohn's Disease Activity Index (PCDAI) [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: November 2011
Estimated Study Completion Date: September 2014
Estimated 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

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444092

  Hide Study Locations
Locations
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
St. 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
AstraZeneca
Investigators
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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01444092     History of Changes
Other Study ID Numbers: D9422C00001
Study First Received: September 28, 2011
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Italy: The Italian Medicines Agency
Germany: Ministry of Health

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Budesonide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 01, 2014