Crohn's DiseasePhase 2NCT00035503
Multicenter Trial For Patients With Acute Crohn's Disease
A Phase 2 study testing etiprednol dicloacetate in people with Crohn's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 11 sites in 2 countries.
Trial summary
The purpose of this study is to see if etiprednol dicloacetate is safe and effective for the treatment of acute Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- etiprednol dicloacetate
- How many people
- Not given
- Where
- 11 sitesin 2 countries
- Study dates
- 31 Jan 2002to 31 Jan 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Must have active confirmed Crohn's disease with CDAI > 220 and < 400.
- Otherwise healthy.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
Richard MacDermott
Albany, New York, 12208
University of Chicago Hospital Medical Center
Chicago, Illinois, 60637
University of Colorado Medical Center
Denver, Colorado, 80262
Mark Lamet
Hollywood, Florida, 33021
Wayne Schonfeld
Hollywood, Florida, 33021
Gerald Dryden
Louisville, Kentucky, 40202
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Stuart Weisman
Palo Alto, California, 94304
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Canada2 sites
Gary Wild
Montreal, Quebec, H3G 1A4
Hillary Steinhart
Toronto, Ontario, M5G 1XB
About this study
The purpose of this study is to see if etiprednol dicloacetate is safe and effective for the treatment of acute Crohn's disease.
- Conditions
- Crohn's Disease
- Being tested
- etiprednol dicloacetate
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etiprednol dicloacetateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2002 (estimated)
- Study start31 Jan 2002
- Primary completion31 Jan 2004
- Study completion31 Jan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035503
- Sponsor's protocol ID
- IXR-201-19-166
- Status last verified
- Dec 2021
- First submitted
- 3 May 2002
- Last updated
- 8 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial For Patients With Acute Crohn's Disease
- ClinicalTrials.gov ID
- NCT00035503
- Acronym / sponsor ID
- IXR-201-19-166
- Conditions
- Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2002 (actual)
- Primary completion
- 31 Jan 2004 (actual)
- Study completion
- 31 Jan 2004 (actual)
- First posted
- 6 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if etiprednol dicloacetate is safe and effective for the treatment of acute Crohn's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etiprednol dicloacetate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing etiprednol dicloacetate in people with Crohn's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.