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Multicenter Trial For Patients With Acute Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
etiprednol dicloacetate
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Must have active confirmed Crohn's disease with CDAI > 220 and < 400. Otherwise healthy.

Sites / Locations

  • Stuart Weisman
  • University of Colorado Medical Center
  • Washington Hospital Center
  • Mark Lamet
  • Wayne Schonfeld
  • Mount Sinai Medical Center
  • University of Chicago Hospital Medical Center
  • Gerald Dryden
  • Richard MacDermott
  • Hillary Steinhart
  • Gary Wild

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 3, 2002
Last Updated
December 1, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00035503
Brief Title
Multicenter Trial For Patients With Acute Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2002 (Actual)
Primary Completion Date
January 31, 2004 (Actual)
Study Completion Date
January 31, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see if etiprednol dicloacetate is safe and effective for the treatment of acute Crohn's disease.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
etiprednol dicloacetate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Must have active confirmed Crohn's disease with CDAI > 220 and < 400. Otherwise healthy.
Facility Information:
Facility Name
Stuart Weisman
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Mark Lamet
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Wayne Schonfeld
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
University of Chicago Hospital Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Gerald Dryden
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Richard MacDermott
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Hillary Steinhart
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1XB
Country
Canada
Facility Name
Gary Wild
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

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Multicenter Trial For Patients With Acute Crohn's Disease

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