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CompletedNCT00035503Updated Dec 8, 2021

Multicenter Trial For Patients With Acute Crohn's Disease

A Phase 2 interventional study of etiprednol dicloacetate in Crohn's Disease, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-08.

Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2002, registered May 2002).
Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Crohn's Disease

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

Browse Crohn Disease studies →

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • Must have active confirmed Crohn's disease with CDAI > 220 and \< 400.
  • Otherwise healthy.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double

Interventions

  • Drugetiprednol dicloacetate
06

Study locations

11 sites
  • Stuart Weisman
    Palo Alto, California 94304, United States
  • University of Colorado Medical Center
    Denver, Colorado 80262, United States
  • Washington Hospital Center
    Washington, District of Columbia 20010, United States
  • Mark Lamet
    Hollywood, Florida 33021, United States
  • Wayne Schonfeld
    Hollywood, Florida 33021, United States
  • Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
  • University of Chicago Hospital Medical Center
    Chicago, Illinois 60637, United States
  • Gerald Dryden
    Louisville, Kentucky 40202, United States
  • Richard MacDermott
    Albany, New York 12208, United States
  • Hillary Steinhart
    Toronto, Ontario M5G 1XB, Canada
  • Gary Wild
    Montreal, Quebec H3G 1A4, Canada
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00035503
Lead sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Responsible party
Sponsor
First posted
May 6, 2002
Start date
Jan 31, 2002
Primary completion
Jan 31, 2004
Completion
Jan 31, 2004
Last update
Dec 8, 2021
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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