Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD) Clinical Trial

Official title:

Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00152620
• Other study ID #: 13171B
• Status: Terminated
• Phase: N/A
• First received: September 7, 2005
• Last updated: September 4, 2013
• Start date: June 2004
• Est. completion date: May 2007

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammatory Bowel Disease (IBD)
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• Dexamethasone

• Methylprednisolone

Locations

Country	Name	City	State
United States	University of Chicago Comer Children's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (13)

Barnes PJ, Adcock I. Anti-inflammatory actions of steroids: molecular mechanisms. Trends Pharmacol Sci. 1993 Dec;14(12):436-41. Review. — View 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. Review. — View Citation

Campieri M. New steroids and new salicylates in inflammatory bowel disease: a critical appraisal. Gut. 2002 May;50 Suppl 3:III43-6. Review. — View 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. — View Citation

EDWARDS FC, TRUELOVE SC. THE COURSE AND PROGNOSIS OF ULCERATIVE COLITIS. III. COMPLICATIONS. Gut. 1964 Feb;5:1-22. — View 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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

Stein RB, Hanauer SB. Medical therapy for inflammatory bowel disease. Gastroenterol Clin North Am. 1999 Jun;28(2):297-321. Review. — View Citation

Truelove SC, Jewell DP. Intensive intravenous regimen for severe attacks of ulcerative colitis. Lancet. 1974 Jun 1;1(7866):1067-70. — View Citation

Truelove SC. The management of ulcerative colitis. Br J Clin Pract. 1974 Jan;28(1):5-10. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Crohn's Disease Activity Index (PCDAI)
Primary	Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis
Secondary	Partial Harvey Bradshaw score (pHB)