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Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Disease (IBD)

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone

Methylprednisolone

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease (IBD) focused on measuring Inflammatory Bowel Disease (IBD)

Eligibility Criteria

6 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Chicago Comer Children's Hospital

Outcomes

Primary Outcome Measures

Pediatric Crohn's Disease Activity Index (PCDAI)

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

Secondary Outcome Measures

Partial Harvey Bradshaw score (pHB)

Full Information

NCT ID

NCT00152620

First Posted

September 7, 2005

Last Updated

September 4, 2013

Sponsor

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT00152620

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Terminated

Why Stopped

study completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Disease (IBD)

Keywords

Inflammatory Bowel Disease (IBD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Primary Outcome Measure Information:

Title

Pediatric Crohn's Disease Activity Index (PCDAI)

Title

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

Secondary Outcome Measure Information:

Title

Partial Harvey Bradshaw score (pHB)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara S Kirschner, MD

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Chicago Comer Children's Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

14127503

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.

Results Reference

background

PubMed Identifier

4149894

Citation

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

Results Reference

background

PubMed Identifier

1934694

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.

Results Reference

background

PubMed Identifier

7510080

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.

Results Reference

background

PubMed Identifier

9741018

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.

Results Reference

background

PubMed Identifier

4135487

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.

Results Reference

background

PubMed Identifier

10372270

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.

Results Reference

background

PubMed Identifier

3031150

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.

Results Reference

background

PubMed Identifier

168121

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.

Results Reference

background

PubMed Identifier

11040177

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.

Results Reference

background

PubMed Identifier

12352296

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.

Results Reference

background

PubMed Identifier

14551176

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.

Results Reference

background

PubMed Identifier

11953332

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.

Results Reference

background

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Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease

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