Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease
Information source: University of Chicago
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Inflammatory Bowel Disease (IBD)
Intervention: Dexamethasone (Drug); Methylprednisolone (Drug)
Phase: N/A
Status: Terminated
Sponsored by: University of Chicago Official(s) and/or principal investigator(s):
Barbara S Kirschner, MD, Principal Investigator, Affiliation: University of Chicago
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.
Clinical Details
Official title: Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease
Study design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment
Primary outcome: Pediatric Crohn's Disease Activity Index (PCDAI)Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis
Secondary outcome: Partial Harvey Bradshaw score (pHB)
Eligibility
Minimum age: 6 Years.
Maximum age: 19 Years.
Gender(s): Both.
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
Locations and Contacts
University of Chicago Comer Children's Hospital, Chicago, Illinois 60637, United States
Additional Information
Related publications: EDWARDS FC, TRUELOVE SC. THE COURSE AND PROGNOSIS OF ULCERATIVE COLITIS. III. COMPLICATIONS. Gut. 1964 Feb;32:1-22. No abstract available. Truelove SC. The management of ulcerative colitis. Br J Clin Pract. 1974 Jan;28(1):5-10. No abstract available. Boumpas DT, Paliogianni F, Anastassiou ED, Balow JE. Glucocorticosteroid action on the immune system: molecular and cellular aspects. Clin Exp Rheumatol. 1991 Jul-Aug;9(4):413-23. Review. Barnes PJ, Adcock I. Anti-inflammatory actions of steroids: molecular mechanisms. Trends Pharmacol Sci. 1993 Dec;14(12):436-41. Review. Chun A, Chadi RM, Korelitz BI, Colonna T, Felder JB, Jackson MH, Morgenstern EH, Rubin SD, Sacknoff AG, Gleim GM. Intravenous corticotrophin vs. hydrocortisone in the treatment of hospitalized patients with Crohn's disease: a randomized double-blind study and follow-up. Inflamm Bowel Dis. 1998 Aug;4(3):177-81. Truelove SC, Jewell DP. Intensive intravenous regimen for severe attacks of ulcerative colitis. Lancet. 1974 Jun 1;1(7866):1067-70. No abstract available. Stein RB, Hanauer SB. Medical therapy for inflammatory bowel disease. Gastroenterol Clin North Am. 1999 Jun;28(2):297-321. Review. Meyers S, Lerer PK, Feuer EJ, Johnson JW, Janowitz HD. Predicting the outcome of corticoid therapy for acute ulcerative colitis. Results of a prospective, randomized, double-blind clinical trial. J Clin Gastroenterol. 1987 Feb;9(1):50-4. Kaplan HP, Portnoy B, Binder HJ, Amatruda T, Spiro H. A controlled evaluation of intravenous adrenocorticotropic hormone and hydrocortisone in the treatment of acute colitis. Gastroenterology. 1975 Jul;69(1):91-5. Panes J, Esteve M, Cabre E, Hinojosa J, Andreu M, Sans M, Fernandez-Banares F, Feu F, Gassull MA, Pique JM. Comparison of heparin and steroids in the treatment of moderate and severe ulcerative colitis. Gastroenterology. 2000 Oct;119(4):903-8. Sood A, Midha V, Sood N, Awasthi G. A prospective, open-label trial assessing dexamethasone pulse therapy in moderate to severe ulcerative colitis. J Clin Gastroenterol. 2002 Oct;35(4):328-31. Mager DE, Lin SX, Blum RA, Lates CD, Jusko WJ. Dose equivalency evaluation of major corticosteroids: pharmacokinetics and cell trafficking and cortisol dynamics. J Clin Pharmacol. 2003 Nov;43(11):1216-27. Campieri M. New steroids and new salicylates in inflammatory bowel disease: a critical appraisal. Gut. 2002 May;50 Suppl 3:III43-6. Review.
Starting date: June 2004
Last updated: April 30, 2007
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