Expired Study
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Chicago, Illinois 60637


Purpose:

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.


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


Study is Available At:


Original ID:

13171B


NCT ID:

NCT00152620


Secondary ID:


Study Acronym:


Brief Title:

Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease


Official Title:

Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

6 Years


Maximum Age:

19 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Chicago


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

study completed


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Sing


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:


Overall Contact Information

Official Name:Barbara S Kirschner, MD
Principal Investigator
University of Chicago

Study Dates

Start Date:June 2004
Completion Date:May 2007
Completion Type:Actual
Verification Date:September 2013
Last Changed Date:September 4, 2013
First Received Date:September 7, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Pediatric Crohn's Disease Activity Index (PCDAI)
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Partial Harvey Bradshaw score (pHB)
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Dexamethasone
Intervention Type:Drug
Name:Methylprednisolone

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Chicago

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Campieri M. New steroids and new salicylates in inflammatory bowel disease: a critical appraisal. Gut. 2002 May;50 Suppl 3:III43-6. Review.
PMID:11953332
Reference Type:Reference
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.
PMID:14551176
Reference Type:Reference
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.
PMID:12352296
Reference Type:Reference
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.
PMID:11040177
Reference Type:Reference
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.
PMID:168121
Reference Type:Reference
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.
PMID:3031150
Reference Type:Reference
Citation:Stein RB, Hanauer SB. Medical therapy for inflammatory bowel disease. Gastroenterol Clin North Am. 1999 Jun;28(2):297-321. Review.
PMID:10372270
Reference Type:Reference
Citation:Truelove SC, Jewell DP. Intensive intravenous regimen for severe attacks of ulcerative colitis. Lancet. 1974 Jun 1;1(7866):1067-70. No abstract available.
PMID:4135487
Reference Type:Reference
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.
PMID:9741018
Reference Type:Reference
Citation:Barnes PJ, Adcock I. Anti-inflammatory actions of steroids: molecular mechanisms. Trends Pharmacol Sci. 1993 Dec;14(12):436-41. Review.
PMID:7510080
Reference Type:Reference
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.
PMID:1934694
Reference Type:Reference
Citation:Truelove SC. The management of ulcerative colitis. Br J Clin Pract. 1974 Jan;28(1):5-10. No abstract available.
PMID:4149894
Reference Type:Reference
Citation:EDWARDS FC, TRUELOVE SC. THE COURSE AND PROGNOSIS OF ULCERATIVE COLITIS. III. COMPLICATIONS. Gut. 1964 Feb;32:1-22. No abstract available.
PMID:14127503

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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