Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease

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The University of Chicago

Status

Terminated

Conditions

Inflammatory Bowel Disease (IBD)

Treatments

Drug: Dexamethasone
Drug: Methylprednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT00152620
13171B

Details and patient eligibility

About

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.

Sex

All

Ages

6 to 19 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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