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Safety Study of Entocort for Children With Crohn's Disease

This study is currently recruiting participants.
Verified May 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01444092
First received: September 28, 2011
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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: 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:

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Budesonide
U.S. FDA Resources

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 ]

Estimated Enrollment: 110
Study Start Date: November 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444092

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com

  Show 30 Study Locations
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: May 15, 2013
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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 22, 2013