Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease

NCT00152620 | Terminated

• 1 other identifier: 13171B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease (IBD)

Keywords

Inflammatory Bowel Disease (IBD)

Outcome Measures

Primary Outcomes (2)

• Pediatric Crohn's Disease Activity Index (PCDAI)

• Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis

Secondary Outcomes (1)

• Partial Harvey Bradshaw score (pHB)

Interventions

Dexamethasone DRUG

Methylprednisolone DRUG

Eligibility Criteria

• Age: 6 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Comer Children's Hospital

Chicago, Illinois, 60637, United States

Location

Related Publications (13)

• 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.

  PMID: 14127503 BACKGROUND

• Truelove SC. The management of ulcerative colitis. Br J Clin Pract. 1974 Jan;28(1):5-10. No abstract available.

  PMID: 4149894 BACKGROUND

• 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.

  PMID: 1934694 BACKGROUND

• 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.

  PMID: 7510080 BACKGROUND

• 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.

  PMID: 9741018 BACKGROUND

• 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.

  PMID: 4135487 BACKGROUND

• 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.

  PMID: 10372270 BACKGROUND

• 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.

  PMID: 3031150 BACKGROUND

• 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.

  PMID: 168121 BACKGROUND

• 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.

  PMID: 11040177 BACKGROUND

• 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.

  PMID: 12352296 BACKGROUND

• 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.

  PMID: 14551176 BACKGROUND

• 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.

  PMID: 11953332 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Dexamethasone; Methylprednisolone

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Prednisolone

Study Officials

• Barbara S Kirschner, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: June 1, 2004
• Study Completion: May 1, 2007
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (1)