Principal Investigator: Cristina Hill, MD

Sub-Investigators: Larry Schafer, MD; Julie Kittelsrud, CNP; Susan Weaver, CNP

Study Coordinator: Linda Randel King, RN

Study Description: Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients with Mild or Moderate Active Ulcerative Colitis. A Multi-center, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, with an Additional Reference Arm Evaluating Asacol^® 2400 mg

Overview: The purpose of this research study is to evaluate the effectiveness and safety of two dosage strengths of budesonide-MMX™ oral formulation, compared to placebo (an inactive substance) and Asacol, in subjects with mild or moderate ulcerative colitis.

The study drug, budesonide-MMX™, is an investigational extended-release formulation of budesonide. An investigational formulation is one that is not approved by the U.S. Food & Drug Administration. Asacol is approved by the FDA for the treatment of ulcerative colitis; however, the outside coating (over-encapsulation) of the tablet used in this study has been modified from the FDA-approved product for the purposes of this study.

There will be no charge for participation in this study. The study drug, study visits and study-related procedures, including colonoscopies and biopsies, will be provided at no charge.

Inclusion Criteria:

• Men and women, between the ages of 18 and 75, suffering from ulcerative colitis for at least 6 months

Main Exclusions:

• Women who are pregnant, breastfeeding or planning to become pregnant
• Patients with either severe ulcerative colitis or infectious colitis
• Patients with liver cirrhosis, or evident hepatic or renal disease or insufficiency
• Patients with Type 1 Diabetes
• Patients with known hepatitis B, hepatitis C or HIV infection
• Patients diagnosed with or with a family history of glaucoma
• Intolerance to salicylates

Contact: Linda Randel King, RN

Phone:    (605) 322-3074

Email:     linda.randelking@avera.org