Clinical trial NCT00152620: Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease
Official title: Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inflammatory Bowel Disease (IBD)
Keywords: Inflammatory Bowel Disease (IBD)
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2005-09-09
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Pediatric Crohn's Disease Activity Index (PCDAI)
measure: Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis
Secondary outcomes:
measure: Partial Harvey Bradshaw score (pHB)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Comer Children's Hospital
state: Illinois
Study officials:
affiliation: University of Chicago
name: Barbara S Kirschner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: EDWARDS FC, TRUELOVE SC. THE COURSE AND PROGNOSIS OF ULCERATIVE COLITIS. III. COMPLICATIONS. Gut. 1964 Feb;5(1):1-22. doi: 10.1136/gut.5.1.1. No abstract available.
citation: Truelove SC. The management of ulcerative colitis. Br J Clin Pract. 1974 Jan;28(1):5-10. No abstract available.
citation: 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.
citation: Barnes PJ, Adcock I. Anti-inflammatory actions of steroids: molecular mechanisms. Trends Pharmacol Sci. 1993 Dec;14(12):436-41. doi: 10.1016/0165-6147(93)90184-l.
citation: 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. doi: 10.1097/00054725-199808000-00001.
citation: Truelove SC, Jewell DP. Intensive intravenous regimen for severe attacks of ulcerative colitis. Lancet. 1974 Jun 1;1(7866):1067-70. doi: 10.1016/s0140-6736(74)90552-2. No abstract available.
citation: Stein RB, Hanauer SB. Medical therapy for inflammatory bowel disease. Gastroenterol Clin North Am. 1999 Jun;28(2):297-321. doi: 10.1016/s0889-8553(05)70058-3.
citation: 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. doi: 10.1097/00004836-198702000-00013.
citation: 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.
citation: 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. doi: 10.1053/gast.2000.18159.
citation: 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. doi: 10.1097/00004836-200210000-00009.
citation: 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. doi: 10.1177/0091270003258651.
citation: Campieri M. New steroids and new salicylates in inflammatory bowel disease: a critical appraisal. Gut. 2002 May;50 Suppl 3(Suppl 3):III43-6. doi: 10.1136/gut.50.suppl_3.iii43.