Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease

• Sponsor: University of Chicago (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00152620
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 35
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease (IBD)	Drug: Dexamethasone; Drug: Methylprednisolone	N/A

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease
• Study Start Date: Jun 1, 2004
• Actual Study Completion Date: May 1, 2007

Outcome Measures

Primary Outcome Measures

1. Pediatric Crohn's Disease Activity Index (PCDAI) []

2. Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis []

Secondary Outcome Measures

1. Partial Harvey Bradshaw score (pHB) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Barnes PJ, Adcock I. Anti-inflammatory actions of steroids: molecular mechanisms. Trends Pharmacol Sci. 1993 Dec;14(12):436-41. Review.
• 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.
• Campieri M. New steroids and new salicylates in inflammatory bowel disease: a critical appraisal. Gut. 2002 May;50 Suppl 3:III43-6. 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.
• EDWARDS FC, TRUELOVE SC. THE COURSE AND PROGNOSIS OF ULCERATIVE COLITIS. III. COMPLICATIONS. Gut. 1964 Feb;5:1-22.
• 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.
• 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.
• 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.
• Panés J, Esteve M, Cabré E, Hinojosa J, Andreu M, Sans M, Fernandez-Bañares F, Feu F, Gassull MA, Piqué 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.
• Stein RB, Hanauer SB. Medical therapy for inflammatory bowel disease. Gastroenterol Clin North Am. 1999 Jun;28(2):297-321. Review.
• Truelove SC, Jewell DP. Intensive intravenous regimen for severe attacks of ulcerative colitis. Lancet. 1974 Jun 1;1(7866):1067-70.
• Truelove SC. The management of ulcerative colitis. Br J Clin Pract. 1974 Jan;28(1):5-10.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT00152620
• Other Study ID Numbers: 13171B
• First Posted: Sep 9, 2005
• Last Update Posted: Sep 5, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by University of Chicago: Inflammatory Bowel Disease (IBD)
• Additional relevant MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Dexamethasone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

No Results Posted as of Sep 5, 2013