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Multicenter Trial For Patients With Acute Crohn's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00035503
First Posted: May 6, 2002
Last Update Posted: February 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
  Purpose
The purpose of this study is to see if etiprednol dicloacetate is safe and effective for the treatment of acute Crohn's disease.

Condition Intervention Phase
Crohn's Disease Drug: etiprednol dicloacetate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):

Study Start Date: January 2002
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Must have active confirmed Crohn's disease with CDAI > 220 and < 400.
  • Otherwise healthy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035503


Locations
United States, California
Stuart Weisman
Palo Alto, California, United States, 94304
United States, Colorado
University of Colorado Medical Center
Denver, Colorado, United States, 80262
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Mark Lamet
Hollywood, Florida, United States, 33021
Wayne Schonfeld
Hollywood, Florida, United States, 33021
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Illinois
University of Chicago Hospital Medical Center
Chicago, Illinois, United States, 60637
United States, Kentucky
Gerald Dryden
Louisville, Kentucky, United States, 40202
United States, New York
Richard MacDermott
Albany, New York, United States, 12208
Canada, Ontario
Hillary Steinhart
Toronto, Ontario, Canada, M5G 1XB
Canada, Quebec
Gary Wild
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
  More Information

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT00035503     History of Changes
Other Study ID Numbers: IXR-201-19-166
First Submitted: May 3, 2002
First Posted: May 6, 2002
Last Update Posted: February 21, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases