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

Tracking Information
First Received Date ^ICMJE	May 3, 2002
Last Updated Date	February 20, 2013
Start Date ^ICMJE	January 2002
Primary Completion Date	January 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00035503 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Multicenter Trial For Patients With Acute Crohn's Disease
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Crohn's Disease
Intervention ^ICMJE	Drug: etiprednol dicloacetate
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	January 2004
Primary Completion Date	January 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Must have active confirmed Crohn's disease with CDAI > 220 and < 400. Otherwise healthy.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT Number ^ICMJE	NCT00035503
Other Study ID Numbers ^ICMJE	IXR-201-19-166
Has Data Monitoring Committee	Not Provided
Responsible Party	Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
Study Sponsor ^ICMJE	Teva Branded Pharmaceutical Products, R&D Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Teva Pharmaceutical Industries
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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