Dexamethasone Versus Methylprednisolone for the Treatment... | NCT00152620

Studies
Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease

NCT00152620

Sponsor

University of Chicago

Status

Terminated

Last Update Posted

Sep 5, 2013Estimated

Enrollment

Phase

Not Applicable

Conditions

Inflammatory Bowel Disease (IBD)

Interventions

Dexamethasone
Methylprednisolone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study completed

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 9, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2013

Last Update Posted Date

Sep 5, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pediatric Crohn's Disease Activity Index (PCDAI)
Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis

Secondary Outcomes

Measure	Description	Time Frame
Partial Harvey Bradshaw score (pHB)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barbara S Kirschner, MD	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago Comer Children's Hospital		Chicago	Illinois	60637	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14127503	Background	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.
4149894	Background	Truelove SC. The management of ulcerative colitis. Br J Clin Pract. 1974 Jan;28(1):5-10. No abstract available.

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug
Methylprednisolone	Drug