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

NCT ID: NCT00679432

Last Updated: 2019-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 510 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-06-30

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.

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 If a patient is withdrawn from the study before Day 56, they will be asked to attend the study center as soon as possible thereafter so that the Final visit assessments can be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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1: budesonide-MMX® 6 mg

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.

Group Type: EXPERIMENTAL

Blood sampling, endoscopy

Intervention Type: PROCEDURE

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

budesonide-MMX® 6 mg

Intervention Type: DRUG

6 mg/day, 6 mg tablets

2: budesonide-MMX® 9 mg

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.

Group Type: EXPERIMENTAL

Blood sampling, endoscopy

Intervention Type: PROCEDURE

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

budesonide-MMX® 9 mg

Intervention Type: DRUG

9 mg/day, 9 mg tablets

3: Placebo

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.

Group Type: PLACEBO_COMPARATOR

Blood sampling, endoscopy

Intervention Type: PROCEDURE

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

Placebo

Intervention Type: DRUG

Placebo

4: Asacol® 400 mg

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.

Group Type: ACTIVE_COMPARATOR

Blood sampling, endoscopy

Intervention Type: PROCEDURE

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

Asacol® 400 mg

Intervention Type: DRUG

2400 mg/day, 400 mg tablets

Interventions

Blood sampling, endoscopy

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

Intervention Type: PROCEDURE

budesonide-MMX® 6 mg

6 mg/day, 6 mg tablets

Intervention Type: DRUG

budesonide-MMX® 9 mg

9 mg/day, 9 mg tablets

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Asacol® 400 mg

2400 mg/day, 400 mg tablets

Intervention Type: DRUG

Eligibility 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 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).
• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce Eric Sands

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Santarus Clinical Investigational Site 5051

Huntsville, Alabama, United States

Santarus Clinical Investigational Site 5102

Mobile, Alabama, United States

Santarus Clinical Investigational Site 5014

Sylacauga, Alabama, United States

Santarus Clinical Investigational Site 5088

Tucson, Arizona, United States

Santarus Clinical Investigational Site 5044

Anaheim, California, United States

Santarus Clinical Investigational Site 5099

Encinitas, California, United States

Santarus Clinical Investigational Site 5075

Fremont, California, United States

Santarus Clinical Investigational Site 5087

Lakewood, California, United States

Santarus Clinical Investigational Site 5033

Los Angeles, California, United States

Santarus Clinical Investigational Site 5070

Palm Springs, California, United States

Santarus Clinical Investigational Site 5067

San Diego, California, United States

Santarus Clinical Investigational Site 5028

San Francisco, California, United States

Santarus Clinical Investigational Site 5089

Boynton Beach, Florida, United States

Santarus Clinical Investigational Site 5041

Hollywood, Florida, United States

Santarus Clinical Investigational Site 5055

New Smyrna Beach, Florida, United States

Santarus Clinical Investigational Site 5074

Port Orange, Florida, United States

Santarus Clinical Investigational Site 5032

Tampa, Florida, United States

Santarus Clinical Investigational Site 5009

Tampa, Florida, United States

Santarus Clinical Investigational Site 5110

West Palm Beach, Florida, United States

Santarus Clinical Investigational Site 5047

Winter Park, Florida, United States

Santarus Clinical Investigational Site 5003

Zephyrhills, Florida, United States

Santarus Clinical Investigational Site 5016

Atlanta, Georgia, United States

Santarus Clinical Investigational Site 5056

Columbus, Georgia, United States

Santarus Clinical Investigational Site 5103

Savannah, Georgia, United States

Santarus Clinical Investigational Site 5085

Addison, Illinois, United States

Santarus Clinical Investigational Site 5068

Evanston, Illinois, United States

Santarus Clinical Investigational Site 5086

Bloomington, Indiana, United States

Santarus Clinical Investigational Site 5053

Clive, Iowa, United States

Santarus Clinical Investigational Site 5008

Metairie, Louisiana, United States

Santarus Clinical Investigational Site 5090

Annapolis, Maryland, United States

Santarus Clinical Investigational Site 5025

Baltimore, Maryland, United States

Santarus Clinical Investigational Site 5092

Hollywood, Maryland, United States

Santarus Clinical Investigational Site 5077

Prince Frederick, Maryland, United States

Santarus Clinical Investigational Site 5046

Boston, Massachusetts, United States

Santarus Clinical Investigational Site 5115

Brockton, Massachusetts, United States

Santarus Clinical Investigational Site 5010

Chesterfield, Michigan, United States

Santarus Clinical Investigational Site 5006

Troy, Michigan, United States

Santarus Clinical Investigational Site 5004

Wyoming, Michigan, United States

Santarus Clinical Investigational Site 5105

St Louis, Missouri, United States

Santarus Clinical Investigational Site 5094

Egg Harbor, New Jersey, United States

Santarus Clinical Investigational Site 5005

Marlton, New Jersey, United States

Santarus Clinical Investigational Site 5024

Vineland, New Jersey, United States

Santarus Clinical Investigational Site 5011

Great Neck, New York, United States

Santarus Clinical Investigational Site 5101

New York, New York, United States

Santarus Clinical Investigational Site 5020

Pittsford, New York, United States

Santarus Clinical Investigational Site 5096

Fayetteville, North Carolina, United States

Santarus Clinical Investigational Site 5058

Huntersville, North Carolina, United States

Santarus Clinical Investigational Site 5091

New Bern, North Carolina, United States

Santarus Clinical Investigational Site 5124

Wilmington, North Carolina, United States

Santarus Clinical Investigational Site 5118

Canton, Ohio, United States

Santarus Clinical Investigational Site 5045

Cincinnati, Ohio, United States

Santarus Clinical Investigational Site 5078

Dayton, Ohio, United States

Santarus Clinical Investigational Site 5120

Mentor, Ohio, United States

Santarus Clinical Investigational Site 5066

Duncansville, Pennsylvania, United States

Santarus Clinical Investigational Site 5065

Pottstown, Pennsylvania, United States

Santarus Clinical Investigational Site 5035

Sayre, Pennsylvania, United States

Santarus Clinical Investigational Site 5107

Sioux Falls, South Dakota, United States

Santarus Clinical Investigational Site 5130

Jackson, Tennessee, United States

Santarus Clinical Investigational Site 5095

Kingsport, Tennessee, United States

Santarus Clinical Investigational Site 5021

Austin, Texas, United States

Santarus Clinical Investigational Site 5076

Houston, Texas, United States

Santarus Clinical Investigational Site 5108

Houston, Texas, United States

Santarus Clinical Investigational Site 5019

Houston, Texas, United States

Santarus Clinical Investigational Site 5036

Houston, Texas, United States

Santarus Clinical Investigational Site 5063

Irving, Texas, United States

Santarus Clinical Investigational Site 5072

Kingwood, Texas, United States

Santarus Clinical Investigational Site 5054

La Porte, Texas, United States

Santarus Clinical Investigational Site 5030

Lewisville, Texas, United States

Santarus Clinical Investigational Site 5093

Plano, Texas, United States

Santarus Clinical Investigational Site 5049

San Antonio, Texas, United States

Santarus Clinical Investigational Site 5100

San Antonio, Texas, United States

Santarus Clinical Investigational Site 5079

San Antonio, Texas, United States

Santarus Clinical Investigational Site 5098

Tomball, Texas, United States

Santarus Clinical Investigational Site 5015

Salt Lake City, Utah, United States

Santarus Clinical Investigational Site 5097

Christiansburg, Virginia, United States

Santarus Clinical Investigational Site 5119

Norfolk, Virginia, United States

Santarus Clinical Investigational Site 6005

Abbotsford, British Columbia, Canada

Santarus Clinical Investigational Site 6000

Vancouver, British Columbia, Canada

Santarus Clinical Investigational Site 6014

Vancouver, British Columbia, Canada

Santarus Clinical Investigational Site 6008

Victoria, British Columbia, Canada

Santarus Clinical Investigational Site 6004

Richmond Hill, Ontario, Canada

Santarus Clinical Investigational Site 6017

Toronto, Ontario, Canada

Santarus Clinical Investigational Site 6001

Montreal, Quebec, Canada

Santarus Clinical Investigational Site 6002

Québec, Quebec, Canada

Santarus Clinical Investigational Site 6016

Saskatoon, Saskatchewan, Canada

Santarus Clinical Investigational Site 6006

Toronto, , Canada

Santarus Clinical Investigational Site 9001

Andhra Pradesh, , India

Santarus Clinical Investigational Site 9009

Andhra Pradesh, , India

Santarus Clinical Investigational Site 9012

Andhra Pradesh, , India

Santarus Clinical Investigational Site 9016

Andhra Pradesh, , India

Santarus Clinical Investigational Site 9006

Assam, , India

Santarus Clinical Investigational Site 9007

Gujarat, , India

Santarus Clinical Investigational Site 9004

Karnataka, , India

Santarus Clinical Investigational Site 9015

Karnataka, , India

Santarus Clinical Investigational Site 9003

Kerala, , India

Santarus Clinical Investigational Site 9002

Maharashtra, , India

Santarus Clinical Investigational Site 9008

Maharashtra, , India

Santarus Clinical Investigational Site 9010

Maharashtra, , India

Santarus Clinical Investigational Site 9011

Maharashtra, , India

Santarus Clinical Investigational Site 9013

Maharashtra, , India

Santarus Clinical Investigational Site 9017

Maharashtra, , India

Santarus Clinical Investigational Site 9018

Rajasthan, , India

Santarus Clinical Investigational Site 9005

Tamil Nadu, , India

Santarus Clinical Investigational Site 9014

Uttar Pradesh, , India

Santarus Clinical Investigational Site 7000

Central, La Paz Baja California Sur, Mexico

Countries

United States; Canada; India; Mexico

References

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.

Reference Type: RESULT

PMID: 22892337 (View on PubMed)

Other Identifiers

CB-01-02/01

Identifier Type: -

Identifier Source: org_study_id