Status:
TERMINATED
Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease
Lead Sponsor:
University of Chicago
Conditions:
Inflammatory Bowel Disease (IBD)
Eligibility:
All Genders
6-19 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00152620
Start Date
June 1 2004
End Date
May 1 2007
Last Update
September 5 2013
Active Locations (1)
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1
University of Chicago Comer Children's Hospital
Chicago, Illinois, United States, 60637