NCT00035503

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2002

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2002

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2004

Completed
Last Updated

December 8, 2021

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

May 3, 2002

Last Update Submit

December 1, 2021

Conditions

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Must have active confirmed Crohn's disease with CDAI \> 220 and \< 400. * Otherwise healthy.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

Stuart Weisman

Palo Alto, California, 94304, United States

Location

University of Colorado Medical Center

Denver, Colorado, 80262, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Mark Lamet

Hollywood, Florida, 33021, United States

Location

Wayne Schonfeld

Hollywood, Florida, 33021, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

University of Chicago Hospital Medical Center

Chicago, Illinois, 60637, United States

Location

Gerald Dryden

Louisville, Kentucky, 40202, United States

Location

Richard MacDermott

Albany, New York, 12208, United States

Location

Hillary Steinhart

Toronto, Ontario, M5G 1XB, Canada

Location

Gary Wild

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

etiprednol dicloacetate

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2002

First Posted

May 6, 2002

Study Start

January 31, 2002

Primary Completion

January 31, 2004

Study Completion

January 31, 2004

Last Updated

December 8, 2021

Record last verified: 2021-12

Locations