Ulcerative ColitisNCT00780507
Fecal Biomarker Study for Patients With Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Warner Chilcott at 61 sites in United States.
Trial summary
The present study will analyze fecal levels of FC and FL in UC patients who relapse (flare) while on a QD or a BID Asacol treatment regimen and compare those levels to levels of FC and FL in UC patients who do not relapse (flare). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 89 participants
- Where
- 61 sitesUnited States
- Study dates
- Aug 2007to Jul 2009
- Phase
- Observational
- 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
Study population: The population of ulcerative colitis patients willcome from clients within the United States and are participants in the QDIEM Asacol study (2007021/NCT00505778)
Who may be able to join
- Be willing and able to provide written informed consent for this biomarker study;
- Be enrolled in Study 2007021 (QDIEM).
Who cannot join
- Meet the QDIEM Protocol 2007021 for Exclusion Criteria
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
United States61 sites
Research Facility
Alexandria, Virginia, 22306
Research Facility
Anaheim, California, 92801
Research Facility
Arlington Heights, Illinois, 60005
Research Facility
Babylon, New York, 11702
Research Facility
Binghamton, New York, 13903
Research Facility
Boone, North Carolina, 28607
Research Facility
Bowling Green, Kentucky, 42101
Research Facility
Braintree, Massachusetts, 02184
Research Facility
Canton, Ohio, 44718
Research Facility
Cheektowaga, New York, 14225
Research Facility
Chesapeake, Virginia, 23320
Research Facility
Chesterfield, Michigan, 48047
Research Facility
Cincinnati, Ohio, 45219
Research Facility
Cincinnati, Ohio, 45242
Research Facility
Clive, Iowa, 50325
Research Facility
Decatur, Georgia, 30033
Research Facility
Egg Harbor, New Jersey, 08234
Research Facility
Folsom, California, 95630
Research Facility
Forest Hills, New York, 11375
Research Facility
Fort Lauderdale, Florida, 33308
Research Facility
Greenville, Texas, 75401
Research Facility
Houston, Texas, 77004
Research Facility
Houston, Texas, 77090
Research Facility
Indiana, Pennsylvania, 15701
Research Facility
Jackson, Tennessee, 38301
Research Facility
Jefferson City, Missouri, 65109
Research Facility
Lafayette, Colorado, 80026
Research Facility
Lake Success, New York, 11042
Research Facility
Lancaster, Pennsylvania, 17604
Research Facility
Lewisville, Texas, 75057
Research Facility
Longview, Texas, 75605
Research Facility
Los Angeles, California, 90045
Research Facility
Lowell, Arkansas, 72745
Research Facility
Lutherville, Maryland, 21093
Research Facility
Marietta, Georgia, 30067
Research Facility
Merced, California, 95340
Research Facility
Morganton, North Carolina, 28655
Research Facility
New Bern, North Carolina, 28562
Research Facility
New Port Richey, Florida, 34655
Research Facility
Newnan, Georgia, 30263
Research Facility
Oak Lawn, Illinois, 60453
Research Facility
Odessa, Texas, 79761
Research Facility
Palm Harbor, Florida, 34684
Research Facility
Pasadena, Texas, 77504
Research Facility
Pittsford, New York, 14534
Research Facility
Plano, Texas, 75075
Research Facility
Port Jefferson Station, New York, 11776
Research Facility
Raleigh, North Carolina, 27607
Research Facility
Rochester Hills, Michigan, 48307
Research Facility
San Diego, California, 92117
Research Facility
Shreveport, Louisiana, 71103
Research Facility
South Bend, Indiana, 46601
Research Facility
Spokane, Washington, 99204
Research Facility
Tampa, Florida, 33613
Research Facility
Topeka, Kansas, 66606
Research Facility
Torrington, Connecticut, 06790
Research Facility
Upland, California, 91786
Research Facility
Urbana, Illinois, 61801
Research Facility
Warwick, Rhode Island, 02888
Research Facility
Winchester, Virginia, 22601
Research Facility
Zephyrhills, Florida, 33542
About this study
Official title: Fecal Biomarker Study for Patients From a Once Daily Study for Efficacy in a Ulcerative Colitis Maintenance Study
The present study will analyze fecal levels of FC and FL in UC patients who relapse (flare) while on a QD or a BID Asacol treatment regimen and compare those levels to levels of FC and FL in UC patients who do not relapse (flare).
- Conditions
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients are in a state of remission | |
| 2 | Patients are in a flare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the fecal biomarker calprotectin between the UC patients who relapse (flare) and the UC patients who remain in remission throughout the study while on Asacol regardless of the maintenance regimen.
Measured: one year
Secondary outcomes (1)
To compare the fecal levels of the 2 biomarkers (FC and FL) in patients who are on BID and QD treatment regimens and who remain in remission for the duration of the study;
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startAug 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William S Aronstein, MD, PhD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780507
- Sponsor's protocol ID
- 2007096
- Status last verified
- May 2013
- First submitted
- 24 Oct 2008
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Biomarker Study for Patients From a Once Daily Study for Efficacy in a Ulcerative Colitis Maintenance Study
- ClinicalTrials.gov ID
- NCT00780507
- Acronym / sponsor ID
- 2007096
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 27 Oct 2008 (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 present study will analyze fecal levels of FC and FL in UC patients who relapse (flare) while on a QD or a BID Asacol treatment regimen and compare those levels to levels of FC and FL in UC patients who do not relapse (flare).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients are in a state of remission |
| 2 | – | –Patients are in a flare |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of ulcerative colitis patients willcome from clients within the United States and are participants in the QDIEM Asacol study (2007021/NCT00505778)
Key inclusion criteria (2 listed)
- Be willing and able to provide written informed consent for this biomarker study;
- Be enrolled in Study 2007021 (QDIEM).
Key exclusion criteria (1 listed)
- Meet the QDIEM Protocol 2007021 for Exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare the fecal biomarker calprotectin between the UC patients who relapse (flare) and the UC patients who remain in remission throughout the study while on Asacol regardless of the maintenance regimen.
Time frame: one year
1 secondary outcome
To compare the fecal levels of the 2 biomarkers (FC and FL) in patients who are on BID and QD treatment regimens and who remain in remission for the duration of the study;
Time frame: one year
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 31 May 2013.
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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.
William S Aronstein, MD, PhD study director
Procter and Gamble
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Warner Chilcott at 61 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States. 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.
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.
What does the primary outcome measure?
Compare the fecal biomarker calprotectin between the UC patients who relapse (flare) and the UC patients who remain in remission throughout the study while on Asacol regardless of the maintenance regimen. (time frame: one year). It is what the study was designed to measure, not a finding.
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 31 May 2013.