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Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease

This study has been terminated.
(study completed)
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00152620
First received: September 7, 2005
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

The aim of this therapeutic trial is to compare the response of subjects with active IBD to daily intravenous dexamethasone versus the response to daily intravenous methylprednisolone.


Condition Intervention
Inflammatory Bowel Disease (IBD)
Drug: Dexamethasone
Drug: Methylprednisolone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Pediatric Crohn's Disease Activity Index (PCDAI)
  • Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis

Secondary Outcome Measures:
  • Partial Harvey Bradshaw score (pHB)

Estimated Enrollment: 40
Study Start Date: June 2004
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   6 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parental informed consent
  • Subjects 6 to 19 years of age with confirmed diagnosis of IBD (Crohn's disease, ulcerative colitis or indeterminate colitis), who on admission to the hospital have a PCDAI>15 or a Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis of >10.
  • Infectious causes (viruses, bacteria, parasites) have been ruled out.

Exclusion Criteria:

  • Subjects in which the administration of corticosteroids would be contraindicated such as systemic or enteric infections diagnosed by stool analysis including culture, Clostridium Difficile toxin assay, rotavirus or adenovirus 40/41 antigens.
  • Subjects with enterostomy or colostomy
  • Subjects with one or more of the following conditions: unstable vital signs, acute abdomen, toxic megacolon, intestinal obstruction, intestinal perforation
  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: NCT00152620

Locations
United States, Illinois
University of Chicago Comer Children's Hospital
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Barbara S Kirschner, MD University of Chicago
  More Information

Publications:

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00152620     History of Changes
Other Study ID Numbers: 13171B
Study First Received: September 7, 2005
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Inflammatory Bowel Disease (IBD)

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2014