Multicenter Trial For Patients With Acute Crohn's Disease

December 1, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.
The purpose of this study is to see if etiprednol dicloacetate is safe and effective for the treatment of acute Crohn's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1XB
        • Hillary Steinhart
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Gary Wild
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stuart Weisman
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Hollywood, Florida, United States, 33021
        • Mark Lamet
      • Hollywood, Florida, United States, 33021
        • Wayne Schonfeld
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospital Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Gerald Dryden
    • New York
      • Albany, New York, United States, 12208
        • Richard MacDermott

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2002

Primary Completion (Actual)

January 31, 2004

Study Completion (Actual)

January 31, 2004

Study Registration Dates

First Submitted

May 3, 2002

First Submitted That Met QC Criteria

May 3, 2002

First Posted (Estimate)

May 6, 2002

Study Record Updates

Last Update Posted (Actual)

December 8, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IXR-201-19-166

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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