Mild to Moderate Active Ulcerative Colitis for Adults

Study Summary

The purpose of this research study is to determine if the study drug (a pill) will reduce the inflammation associated with ulcerative colitis and decrease symptoms. The drug is approved by the Food and Drug Administration (FDA) for the treatment of diabetes in adults. It is not approved for the treatment of ulcerative colitis or other types of inflammation, therefore this research study is experimental. This research study is a placebo-controlled study, meaning that half of all patients will be randomly assigned (by chance, like the flip of a coin) to receive the study drug and half will receive placebo (an inactive pill that looks like the actual drug).

Participation Details

Participation in the study will last 14 weeks from the time of starting the study drug. A total of seven office visits will be required, including a prescreening visit, a screening visit, and five follow-up visits. During this study laboratory blood tests will be taken, as well as a flexible sigmoidoscopy with biopsy before and after receiving study drug. The study drug is to be taken twice a day for 12 weeks. You cannot take immunomodulator medications such as tacrolimus (Prograf) or cyclosporine (Neoral) during the study. You may only take the medication azathioprine (Imuran) or 6-mercaptopurine (Purinethol) if you have taken this medication for a minimum of six months prior to the start of the study. You cannot begin using steroid medications such as prednisone during the study, but if you are already taking this medication you will continue it at the current dose. Anti-diarrhea medicines (such as Lomotil or Imodium) will not be permitted during the study.

To qualify for this study you may not be pregnant or nursing, and you must be practicing birth control.

Principal Investigator: Stephen B. Hanauer, MD
Study Coordinators: Heather Brenner, RN, BSN and JoAnna Hitchcock, LPN

For more information, please contact:
Heather Brenner, RN, BSN or JoAnna Hitchcock, LPN
University of Chicago Hospitals
5758 S. Maryland Avenue
Gastroenterology Clinic, DCAM 6B
Chicago, IL 60637
Phone: (773) 702-5382, (773) 702-1935, (773) 702-0719
Fax: (773) 834-3268

IRB: #11635A