(CB-01-02/01)Randomized Placebo Controlled Trial of Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg in Patients With Ulcerative Colitis

Condition(s) targeted: Ulcerative Colitis

Intervention: Blood sampling, endoscopy (Procedure); Budesonide-MMX (Drug); Asacol (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Santarus

Official(s) and/or principal investigator(s):
Bruce Eric Sands, Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Lisa Villicana, Phone: (215) 616-3424, Email: VillicanaL@iconus.com

The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.

Official title: 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 Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To evaluate the clinical efficacy and safety of budesonide-MMX™ (CB-01-02) 6 mg and 9 mg oral tablets in patients with active mild or moderate ulcerative colitis, when administered for 8 weeks, and compared to placebo

Secondary outcome: Efficacy & safety of oral budesonide-MMX 6 mg and 9 mg compared to 3 times daily Asacol®. To evaluate the improvement in rectal bleeding,endoscopic, histological, bio humoral parameters and in the Inflammatory Bowel Disease-Quality of Life questionnaire

Detailed description: Each patient will receive one of the following regimens in the morning after breakfast:

1. one budesonide-MMX™ 6 mg tablet plus two placebo Asacol® over encapsulated tablets, or

2. one budesonide-MMX™ 9 mg tablet plus two placebo Asacol® over encapsulated tablets, or

3. two placebo Asacol® over encapsulated tablets plus one placebo budesonide tablet, or

4. two Asacol® 400 mg over encapsulated tablets plus one placebo budesonide tablet, daily for 8 weeks.

Each patient will also receive on each day after the midday meal and after the evening meal either:

- two Asacol® 400 mg over-encapsulated tablets (Group 4), or

- the equivalent placebo Asacol® over-encapsulated tablets, (Groups 1, 2 and 3)

Hence, each patient is to take seven tablets per day of active or placebo study medication as per the randomization schedule. Placebo tablets of budesonide-MMX™ and placebo over-encapsulated tablets of Asacol® will be used to maintain the study blind using a double-dummy technique.

During the study, five visits to the clinical center are scheduled: one at Screening and three in the double-blind treatment period (Day 1, Day 14, Day 28 and Day 56). A safety follow up visit will take place about 2 weeks after the final study visit. If a patient is withdrawn from the study before Day 56, they will be asked to attend the study center as soon as possible thereafter so that the Final visit assessments can be conducted.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients fulfilling the following criteria at the screening visit are eligible for

participation in the study:

- Male and female patients, 18-75 years old, suffering from ulcerative colitis for

at least 6 months.

- Diagnosis of ulcerative colitis in active phase, of mild or moderate entity with

Ulcerative Colitis Disease Activity Index (UCDAI) ≥ 4 and ≤ 10 according to Sutherland.

- All females of child-bearing potential must have a negative serum pregnancy test

immediately prior to enrollment. In addition, all females of child-bearing potential must agree to be completely abstinent or be using an accepted form of contraception throughout the entire study period. Accepted forms of contraception are defined as those with a failure rate <1% when properly applied and include: combination oral pill, some intra-uterine devices, and a sterilised partner in a stable relationship. Female subjects must also not be actively breast-feeding through the entire study period.

- Ability to comprehend the full nature and purpose of the study, including

possible risks and side effects.

- Ability to co-operate with the investigator and to comply with the requirements

of the entire study.

- Must be able to understand and voluntarily sign written informed consent prior

to inclusion in the study.

Exclusion Criteria:

- Patients who meet any of the following criteria at screening visit are to be excluded

from study participation:

- Patients with limited distal proctitis (from anal verge up to 15 cm above the

pectineal line).

- Patients with severe ulcerative colitis (UCDAI >10).

- Patients with infectious colitis.

- Evidence or history of toxic megacolon.

- Severe anemia, leucopenia or granulocytopenia.

- Use of oral or rectal steroids in the last 4 weeks.

- Use of immuno-suppressive agents in the last 8 weeks before the study.

- Use of anti tumor necrosis factor alpha (anti-TNFα) agents in the last 3 months.

- Concomitant use of any rectal preparation.

- Concomitant use of antibiotics.

- Concurrent use of CYP3A4 inducers or CYP3A4 inhibitors. See Section 4. 2, Table 5

for complete list.

- Patients with intolerance to salicylates.

- Patients with verified, presumed or expected pregnancy or ongoing lactation.

- Patients with liver cirrhosis, or evident hepatic or renal disease or

insufficiency, and/or severe impairment of the bio-humoral parameters (i. e. 2 x upper limit of normal for ALT, AST, GGT or creatinine).

- Patient with severe diseases in other organs and systems.

- Patients with local or systemic complications or other pathological states

requiring a therapy with corticosteroids and/or immuno-suppressive agents.

- Patients diagnosed with type 1 diabetes.

- Patients diagnosed with, or with a family history of, glaucoma.

- All patients with known hepatitis B, hepatitis C or with human immunodeficiency

virus (HIV), according to the local privacy policy.

- Participation in experimental therapeutic studies in the last 3 months. (Note:

patients who participated in observational only studies are not excluded).

- Any other medical condition that in the principal investigator's opinion would

make the administration of the study drug or study procedures hazardous to the subject or obscure the interpretation of adverse events (AEs).

Lisa Villicana, Phone: (215) 616-3424, Email: VillicanaL@iconus.com

Santarus Clinical Investigational Site 6006, Toronto M3N 2V7, Canada; Recruiting

Santarus Clinical Investigational Site 6002, Quebec G1R 2J6, Canada; Recruiting

Santarus Clinical Investigational Site 5051, Huntsville, Alabama 35801, United States; Recruiting

Santarus Clinical Investigational Site 5014, Sylacauga, Alabama 35150, United States; Recruiting

Santarus Clinical Investigational Site 5102, Mobile, Alabama 36606, United States; Recruiting

Santarus Clinical Investigational Site 6014, Vancouver, British Columbia V6Z 2K5, Canada; Recruiting

Santarus Clinical Investigational Site 6005, Abbotsford, British Columbia V2S 3N5, Canada; Recruiting

Santarus Clinical Investigational Site 6000, Vancouver, British Columbia V5Z 1H2, Canada; Recruiting

Santarus Clinical Investigational Site 6008, Victoria, British Columbia V8R 1J8, Canada; Recruiting

Santarus Clinical Investigational Site 5028, San Francisco, California 94117, United States; Recruiting

Santarus Clinical Investigational Site 5044, Anaheim, California 92801, United States; Recruiting

Santarus Clinical Investigational Site 5033, Los Angeles, California 90045, United States; Recruiting

Santarus Clinical Investigational Site 5075, Fremont, California 94536, United States; Recruiting

Santarus Clinical Investigational Site 5070, Palm Springs, California 92262, United States; Recruiting

Santarus Clinical Investigational Site 5067, San Diego, California 92101, United States; Recruiting

Santarus Clinical Investigational Site 5087, Lakewood, California 90712, United States; Recruiting

Santarus Clinical Investigational Site 5099, Encinitas, California 92024, United States; Recruiting

Santarus Clinical Investigational Site 5003, Zephyrhills, Florida 33542, United States; Recruiting

Santarus Clinical Investigational Site 5009, Tampa, Florida 33613, United States; Recruiting

Santarus Clinical Investigational Site 5041, Hollywood, Florida 33021, United States; Recruiting

Santarus Clinical Investigational Site 5055, New Smyrna Beach, Florida 32168, United States; Recruiting

Santarus Clinical Investigational Site 5047, Winter Park, Florida 32789, United States; Recruiting

Santarus Clinical Investigational Site 5032, Tampa, Florida 33607, United States; Recruiting

Santarus Clinical Investigational Site 5074, Port Orange, Florida 32127, United States; Recruiting

Santarus Clinical Investigational Site 5089, Boynton Beach, Florida 33426, United States; Recruiting

Santarus Clinical Investigational Site 5110, West Palm Beach, Florida 33409, United States; Recruiting

Santarus Clinical Investigational Site 5016, Atlanta, Georgia 30312, United States; Recruiting

Santarus Clinical Investigational Site 5056, Columbus, Georgia 31904, United States; Recruiting

Santarus Clinical Investigational Site 5085, Addison, Illinois 60101, United States; Recruiting

Santarus Clinical Investigational Site 5068, Evanston, Illinois 60201, United States; Recruiting

Santarus Clinical Investigational Site 5086, Bloomington, Indiana 47403, United States; Recruiting

Santarus Clinical Investigational Site 5053, Clive, Iowa 50325, United States; Recruiting

Santarus Clinical Investigational Site 7000, Colonia Centra, La Paz Baja California Sur 23000, Mexico; Recruiting

Santarus Clinical Investigational Site 5008, Metairie, Louisiana 70006, United States; Recruiting

Santarus Clinical Investigational Site 5025, Baltimore, Maryland 21229, United States; Recruiting

Santarus Clinical Investigational Site 5077, Prince Frederick, Maryland 20678, United States; Recruiting

Santarus Clinical Investigational Site 5090, Annapolis, Maryland 21401, United States; Recruiting

Santarus Clinical Investigational Site 5092, Hollywood, Maryland 20636, United States; Recruiting

Santarus Clinical Investigational Site 5046, Boston, Massachusetts 02114, United States; Recruiting

Santarus Clinical Investigational Site 5115, Brockton, Massachusetts 02301, United States; Recruiting

Santarus Clinical Investigational Site 5004, Wyoming, Michigan 49519, United States; Recruiting

Santarus Clinical Investigational Site 5006, Troy, Michigan 48098, United States; Recruiting

Santarus Clinical Investigational Site 5010, Chesterfield, Michigan 48047, United States; Recruiting

Santarus Clinical Investigational Site 5105, St Louis, Missouri 63128, United States; Recruiting

Santarus Clinical Investigational Site 5005, Marlton, New Jersey 08053, United States; Recruiting

Santarus Clinical Investigational Site 5024, Vineland, New Jersey 08360, United States; Recruiting

Santarus Clinical Investigational Site 5094, Egg Harbor Township, New Jersey 08234, United States; Recruiting

Santarus Clinical Investigational Site 5011, Great Neck, New York 11021, United States; Recruiting

Santarus Clinical Investigational Site 5020, Pittsford, New York 14534, United States; Recruiting

Santarus Clinical Investigational Site 5101, New York, New York 10016, United States; Recruiting

Santarus Clinical Investigational Site 5058, Huntersville, North Carolina 28078, United States; Recruiting

Santarus Clinical Investigational Site 5091, New Bern, North Carolina 28562, United States; Recruiting

Santarus Clinical Investigational Site 5096, Fayetteville, North Carolina 28304, United States; Recruiting

Santarus Clinical Investigational Site 5045, Cincinnati, Ohio 45219, United States; Recruiting

Santarus Clinical Investigational Site 5078, Dayton, Ohio 45440, United States; Recruiting

Santarus Clinical Investigational Site 6004, Richmond Hill, Ontario L4B 3P8, Canada; Recruiting

Santarus Clinical Investigational Site 6017, Toronto, Ontario M4N 3N5, Canada; Recruiting

Santarus Clinical Investigational Site 5065, Pottstown, Pennsylvania 19464, United States; Recruiting

Santarus Clinical Investigational Site 5066, Duncansville, Pennsylvania 16635, United States; Recruiting

Santarus Clinical Investigational Site 5035, Sayre, Pennsylvania 18840, United States; Recruiting

Santarus Clinical Investigational Site 6001, Montreal, Quebec H1T 2M4, Canada; Recruiting

Santarus Clinical Investigational Site 6016, Saskatoon, Saskatchewan S7N 0W8, Canada; Recruiting

Santarus Clinical Investigational Site 5107, Sioux Falls, South Dakota 57105, United States; Recruiting

Santarus Clinical Investigational Site 5095, Kingsport, Tennessee 37660, United States; Recruiting

Santarus Clinical Investigational Site 5049, San Antonio, Texas 78229, United States; Recruiting

Santarus Clinical Investigational Site 5019, Houston, Texas 77090, United States; Recruiting

Santarus Clinical Investigational Site 5021, Austin, Texas 78745, United States; Recruiting

Santarus Clinical Investigational Site 5054, La Porte, Texas 77571, United States; Recruiting

Santarus Clinical Investigational Site 5063, Irving, Texas 75061, United States; Recruiting

Santarus Clinical Investigational Site 5030, Lewisville, Texas 75057, United States; Recruiting

Santarus Clinical Investigational Site 5072, Kingwood, Texas 77339, United States; Recruiting

Santarus Clinical Investigational Site 5076, Houston, Texas 77034, United States; Recruiting

Santarus Clinical Investigational Site 5079, San Antonio, Texas 78258, United States; Recruiting

Santarus Clinical Investigational Site 5036, Houston, Texas 77090, United States; Recruiting

Santarus Clinical Investigational Site 5098, Tomball, Texas 77375, United States; Recruiting

Santarus Clinical Investigational Site 5093, Plano, Texas 75075, United States; Recruiting

Santarus Clinical Investigational Site 5108, Houston, Texas 77079, United States; Recruiting

Santarus Clinical Investigational Site 5100, San Antonio, Texas 78229, United States; Recruiting

Santarus Clinical Investigational Site 5015, Salt Lake City, Utah 84107, United States; Recruiting

Santarus Clinical Investigational Site 5097, Christianburg, Virginia 24073, United States; Recruiting

Santarus Clinical Investigational Site 5119, Norfolk, Virginia 23502, United States; Recruiting

Starting date: June 2008
Ending date: February 2010
Last updated: August 17, 2009