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Multicenter Trial For Patients With Acute Crohn's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT00035503
First received: May 3, 2002
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Must have active confirmed Crohn's disease with CDAI > 220 and < 400.
  • Otherwise healthy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT00035503     History of Changes
Other Study ID Numbers: IXR-201-19-166
Study First Received: May 3, 2002
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013