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Ulcerative ColitisPhase 2NCT00065065

A Trial of Rosiglitazone for Ulcerative Colitis

A Phase 2 study testing Rosiglitazone in people with Ulcerative Colitis and Inflammatory Bowel Disease, run by James Lewis at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating rosiglitazone: 4 mg tablets or placebo tablets administered orally twice daily for 12 weeks. The purpose of the study is to evaluate the efficacy and safety of rosiglitazone in the treatment of mild to moderately active ulcerative… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Rosiglitazone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
13 sitesUnited States
Study dates
Sep 2002to Jan 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Healthy volunteers accepted
  • Adult, Older adult

INCLUSION CRITERIA: Participants must meet the following criteria for inclusion in the trial:

  • Must sign and date the informed consent form
  • At least 18 years of age
  • Documented diagnosis (endoscopic, surgical or x-ray) of ulcerative colitis (UC)
  • Mild to moderate ulcerative colitis indicated by Disease Activity Index score of greater than or equal to 4 and less than or equal to 10
  • Unless the patient is intolerant of oral 5-ASA therapy, patient must be treated with a minimum of 2 gm daily of an oral 5-ASA agent for a minimum of 4 weeks during the current exacerbation of ulcerative colitis or immediately prior to study entry
  • If treated with oral corticosteroids, dose must not exceed 20 mg per day of Prednisone or equivalent
  • If treated with corticosteroids, dose must be stable for 4 weeks prior to study entry and remain on same dose throughout
  • If treated with 6-mercaptopurine or azathioprine, must have been on medication for 4 months and a stable dose for 2 months prior to study entry
  • If a female of childbearing age, the participant must have a negative serum pregnancy test and have been using a medically approved form of contraceptive birth control for 3 months prior to enrollment. Participants, both male and female, must also be willing to use medically approved contraceptive birth control (at least one barrier method) throughout the study
  • If treated with rectal therapy, dose must be stable for 2 weeks prior to study entry and remain on same dose throughout

EXCLUSION CRITERIA: Participants will be ineligible for participation in the trial if they meet any of the following criteria:

  • Severe ulcerative colitis indicated by Disease Activity Index score of greater than 10
  • Class III or IV congestive heart failure by NYHA classification system
  • Allergy to thiazolidinediones
  • Presence of any medical condition with an expected survival of less than 1 year
  • Participants receiving therapy with cyclosporin, anti-TNF therapy, or methotrexate within the last 2 months of screening
  • Positive stool culture for enteric pathogens (salmonella, shigella, and campylobacter), positive C.difficile toxin, or positive stool ova and parasite exam
  • Positive proteinuria by urine dipstick
  • History of chronic liver disease or baseline liver chemistries greater than the upper limit of normal
  • Diabetes mellitus requiring hypoglycemic agents
  • Participation in study of experimental therapy within 2 months of first screening visit
  • Has any of the following laboratory abnormalities: WBC < 3,000 per uL, Neutrophil < 1,000 cell/cu.mm, Platelets <75,000 per uL, INR > 1.2
  • Participant is female and is pregnant or currently breastfeeding

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Metropolitan Gastroenterology Group Practice/Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • University of Chicago Hospitals

    Chicago, Illinois, 60637

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Atlantic Gastroenterology Associates

    Egg Harbor, New Jersey, 08234

  • Maryland Digestive Diseases Research

    Laurel, Maryland, 20707

  • University of Pennsylvania - Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Minnesota Gastroenterology

    Plymouth, Minnesota, 55446

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Capitol Gastroenterology Consultants

    Silver Spring, Maryland, 20901

  • Avamar Center for Endoscopy

    Warren, Ohio, 44484

Other trials in United States

About this study

Official title: A Randomized, Placebo-controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating rosiglitazone: 4 mg tablets or placebo tablets administered orally twice daily for 12 weeks. The purpose of the study is to evaluate the efficacy and safety of rosiglitazone in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using a standard disease activity index. Calculation of the index requires patients to undergo flexible sigmoidoscopy at the start of the study and at week 12.

Read the detailed description

Ulcerative colitis is a disease characterized by inflammation (the changes that happen when tissues in the body are injured) of all or a portion of the large intestine. There is presently no medical cure for ulcerative colitis, although surgical removal of the colon would cure the disease. Ulcerative colitis is generally treated with medications against diarrhea and infection, medications which suppress the immune system (the body system that protects a person against foreign substances) or with surgery.

It is thought that the chronic inflammation associated with ulcerative colitis may be related to the release of certain chemicals produced by the body. Rosiglitazone has been shown to inhibit the production of some of these chemicals. The active component of rosiglitazone has also been shown to improve colitis in animal models of colitis. The purpose of this study is to evaluate the benefit of the drug for ulcerative colitis by comparing it to placebo.

This is a randomized controlled trial of rosiglitazone versus placebo in patients who have failed to respond to 5-ASA therapy. Participants will be randomized to receive either rosiglitazone 4mg bid or placebo bid twice daily for a total of 12 weeks. Disease activity will be measured using the Disease Activity Index (DAI) at visits 3 through 8. Additional outcomes measured will include histological disease activity (visits 3 and 7) and quality of life using the IBDQ (visits 3 through 8). The principle analyses will be an intent-to-treat analysis to examine the efficacy of rosiglitazone at a dose of 4mg twice daily compared to placebo to achieve a partial or complete response. Additionally, the change in NF-κB activation prior to and following therapy with either placebo or rosiglitazone will be examined using immunohistochemistry techniques.

Being tested
Rosiglitazone, Placebo
Keywords
Rosiglitazone, Ulcerative, Colitis
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases, Ulcer, Colitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RosiglitazoneDrug

    Also called Avandia

    4mg orally twice daily for 12 weeks

  • PlaceboDrug

    pill that looks identical to rosiglitazone

Study groups in NCT00065065
Study groupRoleWhat they receive
RosiglitazoneExperimental4 mg of rosiglitazone taken twice daily for 12 weeks.
Receives: Drug: Rosiglitazone
placeboPlacebo comparatorIdentical in appearance to study drug taken twice daily for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Improvement of Signs and Symptoms of UC at 12 Weeks

    Mayo score decrease >=2 points adjusted for age and smoking status.

    Measured: 12 weeks

Secondary outcomes (2)

  1. Number of Participants With Clinical Remission at 12 Weeks

    Mayo Score <=2 at 12 weeks post intervention

    Measured: 12 weeks

  2. Number of Participants With Endoscopic Remission at 12 Weeks

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2003 (estimated)
  2. Study startSep 2002
  3. Primary completionJan 2008
  4. Study completionJan 2008

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00065065
Sponsor's protocol ID
ROSIE
Other IDs
R01DK059961
Status last verified
Dec 2017
First submitted
16 Jul 2003
Last updated
16 Jan 2018
Data monitoring committee
Yes

Publications

  • Lewis JD, Lichtenstein GR, Deren JJ, Sands BE, Hanauer SB, Katz JA, Lashner B, Present DH, Chuai S, Ellenberg JH, Nessel L, Wu GD; Rosiglitazone for Ulcerative Colitis Study Group. Rosiglitazone for active ulcerative colitis: a randomized placebo-controlled trial. Gastroenterology. 2008 Mar;134(3):688-95. doi: 10.1053/j.gastro.2007.12.012. Epub 2007 Dec 7.

    PubMed 18325386

  • Lewis JD, Chuai S, Nessel L, Lichtenstein GR, Aberra FN, Ellenberg JH. Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis. 2008 Dec;14(12):1660-6. doi: 10.1002/ibd.20520.

    PubMed 18623174

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rosiglitazone in people with Ulcerative Colitis and Inflammatory Bowel Disease, run by James Lewis at 13 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?

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 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 2 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Improvement of Signs and Symptoms of UC at 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00065065, which also lists 2 linked publications.

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 16 Jan 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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