Multicenter Trial For Patients With Acute Crohn's Disease

NCT ID: NCT00035503

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2004-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

etiprednol dicloacetate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Must have active confirmed Crohn's disease with CDAI \> 220 and \< 400.
* Otherwise healthy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stuart Weisman

Palo Alto, California, United States

Site Status

University of Colorado Medical Center

Denver, Colorado, United States

Site Status

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Mark Lamet

Hollywood, Florida, United States

Site Status

Wayne Schonfeld

Hollywood, Florida, United States

Site Status

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

University of Chicago Hospital Medical Center

Chicago, Illinois, United States

Site Status

Gerald Dryden

Louisville, Kentucky, United States

Site Status

Richard MacDermott

Albany, New York, United States

Site Status

Hillary Steinhart

Toronto, Ontario, Canada

Site Status

Gary Wild

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IXR-201-19-166

Identifier Type: -

Identifier Source: org_study_id