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

NCT00679432 | Completed Phase 3 Results

• 1 other identifier: CB-01-02/01
• Study Type: interventional
• Target: 510
• Locations: 4 countries
• Sites: 105

Brief Summary

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Clinical and Endoscopic Remission.

  Clinical and endoscopic remission defined as a Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.

  8 weeks

Secondary Outcomes (2)

• Clinical Improvement.

  8 weeks

• Endoscopic Improvement

  8 weeks

Study Arms (4)

1: budesonide-MMX® 6 mg

EXPERIMENTAL

One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.

Procedure: Blood sampling, endoscopy; Drug: budesonide-MMX® 6 mg

2: budesonide-MMX® 9 mg

EXPERIMENTAL

One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.

Procedure: Blood sampling, endoscopy; Drug: budesonide-MMX® 9 mg

3: Placebo

PLACEBO COMPARATOR

Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.

Procedure: Blood sampling, endoscopy; Drug: Placebo

4: Asacol® 400 mg

ACTIVE COMPARATOR

Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.

Procedure: Blood sampling, endoscopy; Drug: Asacol® 400 mg

Interventions

Blood sampling, endoscopy PROCEDURE

Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores

1: budesonide-MMX® 6 mg; 2: budesonide-MMX® 9 mg; 3: Placebo; 4: Asacol® 400 mg

budesonide-MMX® 6 mg DRUG

6 mg/day, 6 mg tablets

1: budesonide-MMX® 6 mg

budesonide-MMX® 9 mg DRUG

9 mg/day, 9 mg tablets

2: budesonide-MMX® 9 mg

Placebo DRUG

Placebo

3: Placebo

Asacol® 400 mg DRUG

2400 mg/day, 400 mg tablets

4: Asacol® 400 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 cytochrome P450 3A4 (CYP3A4) inducers or CYP3A4 inhibitors.
• 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 alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gamma glutamyl transpeptidase \[GGT\] or creatinine).

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (105)

Santarus Clinical Investigational Site 5051

Huntsville, Alabama, 35801, United States

Location

Santarus Clinical Investigational Site 5102

Mobile, Alabama, 36606, United States

Location

Santarus Clinical Investigational Site 5014

Sylacauga, Alabama, 35150, United States

Location

Santarus Clinical Investigational Site 5088

Tucson, Arizona, 85712, United States

Location

Santarus Clinical Investigational Site 5044

Anaheim, California, 92801, United States

Location

Santarus Clinical Investigational Site 5099

Encinitas, California, 92024, United States

Location

Santarus Clinical Investigational Site 5075

Fremont, California, 94536, United States

Location

Santarus Clinical Investigational Site 5087

Lakewood, California, 90712, United States

Location

Santarus Clinical Investigational Site 5033

Los Angeles, California, 90045, United States

Location

Santarus Clinical Investigational Site 5070

Palm Springs, California, 92262, United States

Location

Santarus Clinical Investigational Site 5067

San Diego, California, 92101, United States

Location

Santarus Clinical Investigational Site 5028

San Francisco, California, 94117, United States

Location

Santarus Clinical Investigational Site 5089

Boynton Beach, Florida, 33426, United States

Location

Santarus Clinical Investigational Site 5041

Hollywood, Florida, 33021, United States

Location

Santarus Clinical Investigational Site 5055

New Smyrna Beach, Florida, 32168, United States

Location

Santarus Clinical Investigational Site 5074

Port Orange, Florida, 32127, United States

Location

Santarus Clinical Investigational Site 5032

Tampa, Florida, 33607, United States

Location

Santarus Clinical Investigational Site 5009

Tampa, Florida, 33613, United States

Location

Santarus Clinical Investigational Site 5110

West Palm Beach, Florida, 33409, United States

Location

Santarus Clinical Investigational Site 5047

Winter Park, Florida, 32789, United States

Location

Santarus Clinical Investigational Site 5003

Zephyrhills, Florida, 33542, United States

Location

Santarus Clinical Investigational Site 5016

Atlanta, Georgia, 30312, United States

Location

Santarus Clinical Investigational Site 5056

Columbus, Georgia, 31904, United States

Location

Santarus Clinical Investigational Site 5103

Savannah, Georgia, 31406, United States

Location

Santarus Clinical Investigational Site 5085

Addison, Illinois, 60101, United States

Location

Santarus Clinical Investigational Site 5068

Evanston, Illinois, 60201, United States

Location

Santarus Clinical Investigational Site 5086

Bloomington, Indiana, 47403, United States

Location

Santarus Clinical Investigational Site 5053

Clive, Iowa, 50325, United States

Location

Santarus Clinical Investigational Site 5008

Metairie, Louisiana, 70006, United States

Location

Santarus Clinical Investigational Site 5090

Annapolis, Maryland, 21401, United States

Location

Santarus Clinical Investigational Site 5025

Baltimore, Maryland, 21229, United States

Location

Santarus Clinical Investigational Site 5092

Hollywood, Maryland, 20636, United States

Location

Santarus Clinical Investigational Site 5077

Prince Frederick, Maryland, 20678, United States

Location

Santarus Clinical Investigational Site 5046

Boston, Massachusetts, 02114, United States

Location

Santarus Clinical Investigational Site 5115

Brockton, Massachusetts, 02301, United States

Location

Santarus Clinical Investigational Site 5010

Chesterfield, Michigan, 48047, United States

Location

Santarus Clinical Investigational Site 5006

Troy, Michigan, 48098, United States

Location

Santarus Clinical Investigational Site 5004

Wyoming, Michigan, 49519, United States

Location

Santarus Clinical Investigational Site 5105

St Louis, Missouri, 63128, United States

Location

Santarus Clinical Investigational Site 5094

Egg Harbor, New Jersey, 08234, United States

Location

Santarus Clinical Investigational Site 5005

Marlton, New Jersey, 08053, United States

Location

Santarus Clinical Investigational Site 5024

Vineland, New Jersey, 08360, United States

Location

Santarus Clinical Investigational Site 5011

Great Neck, New York, 11021, United States

Location

Santarus Clinical Investigational Site 5101

New York, New York, 10016, United States

Location

Santarus Clinical Investigational Site 5020

Pittsford, New York, 14534, United States

Location

Santarus Clinical Investigational Site 5096

Fayetteville, North Carolina, 28304, United States

Location

Santarus Clinical Investigational Site 5058

Huntersville, North Carolina, 28078, United States

Location

Santarus Clinical Investigational Site 5091

New Bern, North Carolina, 28562, United States

Location

Santarus Clinical Investigational Site 5124

Wilmington, North Carolina, 28403, United States

Location

Santarus Clinical Investigational Site 5118

Canton, Ohio, 44701, United States

Location

Santarus Clinical Investigational Site 5045

Cincinnati, Ohio, 45218, United States

Location

Santarus Clinical Investigational Site 5078

Dayton, Ohio, 45440, United States

Location

Santarus Clinical Investigational Site 5120

Mentor, Ohio, 44060, United States

Location

Santarus Clinical Investigational Site 5066

Duncansville, Pennsylvania, 16635, United States

Location

Santarus Clinical Investigational Site 5065

Pottstown, Pennsylvania, 19464, United States

Location

Santarus Clinical Investigational Site 5035

Sayre, Pennsylvania, 18840, United States

Location

Santarus Clinical Investigational Site 5107

Sioux Falls, South Dakota, 57105, United States

Location

Santarus Clinical Investigational Site 5130

Jackson, Tennessee, 38305, United States

Location

Santarus Clinical Investigational Site 5095

Kingsport, Tennessee, 37660, United States

Location

Santarus Clinical Investigational Site 5021

Austin, Texas, 78745, United States

Location

Santarus Clinical Investigational Site 5076

Houston, Texas, 77034, United States

Location

Santarus Clinical Investigational Site 5108

Houston, Texas, 77079, United States

Location

Santarus Clinical Investigational Site 5019

Houston, Texas, 77090, United States

Location

Santarus Clinical Investigational Site 5036

Houston, Texas, 77090, United States

Location

Santarus Clinical Investigational Site 5063

Irving, Texas, 75061, United States

Location

Santarus Clinical Investigational Site 5072

Kingwood, Texas, 77339, United States

Location

Santarus Clinical Investigational Site 5054

La Porte, Texas, 77571, United States

Location

Santarus Clinical Investigational Site 5030

Lewisville, Texas, 75057, United States

Location

Santarus Clinical Investigational Site 5093

Plano, Texas, 75075, United States

Location

Santarus Clinical Investigational Site 5049

San Antonio, Texas, 78229, United States

Location

Santarus Clinical Investigational Site 5100

San Antonio, Texas, 78229, United States

Location

Santarus Clinical Investigational Site 5079

San Antonio, Texas, 78258, United States

Location

Santarus Clinical Investigational Site 5098

Tomball, Texas, 77375, United States

Location

Santarus Clinical Investigational Site 5015

Salt Lake City, Utah, 84107, United States

Location

Santarus Clinical Investigational Site 5097

Christiansburg, Virginia, 24073, United States

Location

Santarus Clinical Investigational Site 5119

Norfolk, Virginia, 23502, United States

Location

Santarus Clinical Investigational Site 6005

Abbotsford, British Columbia, V2S 3N5, Canada

Location

Santarus Clinical Investigational Site 6000

Vancouver, British Columbia, V5Z 1H2, Canada

Location

Santarus Clinical Investigational Site 6014

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Santarus Clinical Investigational Site 6008

Victoria, British Columbia, V8R 1J8, Canada

Location

Santarus Clinical Investigational Site 6004

Richmond Hill, Ontario, L4B 3P8, Canada

Location

Santarus Clinical Investigational Site 6017

Toronto, Ontario, M4N 3N5, Canada

Location

Santarus Clinical Investigational Site 6001

Montreal, Quebec, H1T 2M4, Canada

Location

Santarus Clinical Investigational Site 6002

Québec, Quebec, G1R 2J6, Canada

Location

Santarus Clinical Investigational Site 6016

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Santarus Clinical Investigational Site 6006

Toronto, M3N 2V7, Canada

Location

Santarus Clinical Investigational Site 9001

Andhra Pradesh, India

Location

Santarus Clinical Investigational Site 9009

Andhra Pradesh, India

Location

Santarus Clinical Investigational Site 9012

Andhra Pradesh, India

Location

Santarus Clinical Investigational Site 9016

Andhra Pradesh, India

Location

Santarus Clinical Investigational Site 9006

Assam, India

Location

Santarus Clinical Investigational Site 9007

Gujarat, India

Location

Santarus Clinical Investigational Site 9004

Karnataka, India

Location

Santarus Clinical Investigational Site 9015

Karnataka, India

Location

Santarus Clinical Investigational Site 9003

Kerala, India

Location

Santarus Clinical Investigational Site 9002

Maharashtra, India

Location

Santarus Clinical Investigational Site 9008

Maharashtra, India

Location

Santarus Clinical Investigational Site 9010

Maharashtra, India

Location

Santarus Clinical Investigational Site 9011

Maharashtra, India

Location

Santarus Clinical Investigational Site 9013

Maharashtra, India

Location

Santarus Clinical Investigational Site 9017

Maharashtra, India

Location

Santarus Clinical Investigational Site 9018

Rajasthan, India

Location

Santarus Clinical Investigational Site 9005

Tamil Nadu, India

Location

Santarus Clinical Investigational Site 9014

Uttar Pradesh, India

Location

Santarus Clinical Investigational Site 7000

Central, La Paz Baja California Sur, 23000, Mexico

Location

Related Publications (1)

• Sandborn WJ, Travis S, Moro L, Jones R, Gautille T, Bagin R, Huang M, Yeung P, Ballard ED 2nd. Once-daily budesonide MMX(R) extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology. 2012 Nov;143(5):1218-1226.e2. doi: 10.1053/j.gastro.2012.08.003. Epub 2012 Aug 11.

  PMID: 22892337 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Blood Specimen Collection; Endoscopy; Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Results Point of Contact

• Title: Michael Huang, MD, Senior Medical Director, Clinical Research
• Organization: Santarus, Inc.

mhuang@santarus.com

8583145700

Study Officials

• Bruce Eric Sands

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 10, 2019
• Results First Posted: August 1, 2014

Record last verified: 2019-11

Locations

ME (1); US (76); IN (18); CA (10)