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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Blood sampling, endoscopy
budesonide-MMX® 6 mg
budesonide-MMX® 9 mg
Placebo
Asacol® 400 mg
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Santarus Clinical Investigational Site 5051
  • Santarus Clinical Investigational Site 5102
  • Santarus Clinical Investigational Site 5014
  • Santarus Clinical Investigational Site 5088
  • Santarus Clinical Investigational Site 5044
  • Santarus Clinical Investigational Site 5099
  • Santarus Clinical Investigational Site 5075
  • Santarus Clinical Investigational Site 5087
  • Santarus Clinical Investigational Site 5033
  • Santarus Clinical Investigational Site 5070
  • Santarus Clinical Investigational Site 5067
  • Santarus Clinical Investigational Site 5028
  • Santarus Clinical Investigational Site 5089
  • Santarus Clinical Investigational Site 5041
  • Santarus Clinical Investigational Site 5055
  • Santarus Clinical Investigational Site 5074
  • Santarus Clinical Investigational Site 5032
  • Santarus Clinical Investigational Site 5009
  • Santarus Clinical Investigational Site 5110
  • Santarus Clinical Investigational Site 5047
  • Santarus Clinical Investigational Site 5003
  • Santarus Clinical Investigational Site 5016
  • Santarus Clinical Investigational Site 5056
  • Santarus Clinical Investigational Site 5103
  • Santarus Clinical Investigational Site 5085
  • Santarus Clinical Investigational Site 5068
  • Santarus Clinical Investigational Site 5086
  • Santarus Clinical Investigational Site 5053
  • Santarus Clinical Investigational Site 5008
  • Santarus Clinical Investigational Site 5090
  • Santarus Clinical Investigational Site 5025
  • Santarus Clinical Investigational Site 5092
  • Santarus Clinical Investigational Site 5077
  • Santarus Clinical Investigational Site 5046
  • Santarus Clinical Investigational Site 5115
  • Santarus Clinical Investigational Site 5010
  • Santarus Clinical Investigational Site 5006
  • Santarus Clinical Investigational Site 5004
  • Santarus Clinical Investigational Site 5105
  • Santarus Clinical Investigational Site 5094
  • Santarus Clinical Investigational Site 5005
  • Santarus Clinical Investigational Site 5024
  • Santarus Clinical Investigational Site 5011
  • Santarus Clinical Investigational Site 5101
  • Santarus Clinical Investigational Site 5020
  • Santarus Clinical Investigational Site 5096
  • Santarus Clinical Investigational Site 5058
  • Santarus Clinical Investigational Site 5091
  • Santarus Clinical Investigational Site 5124
  • Santarus Clinical Investigational Site 5118
  • Santarus Clinical Investigational Site 5045
  • Santarus Clinical Investigational Site 5078
  • Santarus Clinical Investigational Site 5120
  • Santarus Clinical Investigational Site 5066
  • Santarus Clinical Investigational Site 5065
  • Santarus Clinical Investigational Site 5035
  • Santarus Clinical Investigational Site 5107
  • Santarus Clinical Investigational Site 5130
  • Santarus Clinical Investigational Site 5095
  • Santarus Clinical Investigational Site 5021
  • Santarus Clinical Investigational Site 5076
  • Santarus Clinical Investigational Site 5108
  • Santarus Clinical Investigational Site 5019
  • Santarus Clinical Investigational Site 5036
  • Santarus Clinical Investigational Site 5063
  • Santarus Clinical Investigational Site 5072
  • Santarus Clinical Investigational Site 5054
  • Santarus Clinical Investigational Site 5030
  • Santarus Clinical Investigational Site 5093
  • Santarus Clinical Investigational Site 5049
  • Santarus Clinical Investigational Site 5100
  • Santarus Clinical Investigational Site 5079
  • Santarus Clinical Investigational Site 5098
  • Santarus Clinical Investigational Site 5015
  • Santarus Clinical Investigational Site 5097
  • Santarus Clinical Investigational Site 5119
  • Santarus Clinical Investigational Site 6005
  • Santarus Clinical Investigational Site 6000
  • Santarus Clinical Investigational Site 6014
  • Santarus Clinical Investigational Site 6008
  • Santarus Clinical Investigational Site 6004
  • Santarus Clinical Investigational Site 6017
  • Santarus Clinical Investigational Site 6001
  • Santarus Clinical Investigational Site 6016
  • Santarus Clinical Investigational Site 6002
  • Santarus Clinical Investigational Site 6006
  • Santarus Clinical Investigational Site 9001
  • Santarus Clinical Investigational Site 9009
  • Santarus Clinical Investigational Site 9012
  • Santarus Clinical Investigational Site 9016
  • Santarus Clinical Investigational Site 9006
  • Santarus Clinical Investigational Site 9007
  • Santarus Clinical Investigational Site 9004
  • Santarus Clinical Investigational Site 9015
  • Santarus Clinical Investigational Site 9003
  • Santarus Clinical Investigational Site 9002
  • Santarus Clinical Investigational Site 9008
  • Santarus Clinical Investigational Site 9010
  • Santarus Clinical Investigational Site 9011
  • Santarus Clinical Investigational Site 9013
  • Santarus Clinical Investigational Site 9017
  • Santarus Clinical Investigational Site 9018
  • Santarus Clinical Investigational Site 9005
  • Santarus Clinical Investigational Site 9014
  • Santarus Clinical Investigational Site 7000

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

1: budesonide-MMX® 6 mg

2: budesonide-MMX® 9 mg

3: Placebo

4: Asacol® 400 mg

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical Improvement.
Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.
Endoscopic Improvement
Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8. As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted.

Full Information

First Posted
May 14, 2008
Last Updated
November 26, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00679432
Brief Title
(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With 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 Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: one budesonide-MMX™ 6 mg tablet plus two placebo Asacol® over encapsulated tablets, or one budesonide-MMX™ 9 mg tablet plus two placebo Asacol® over encapsulated tablets, or two placebo Asacol® over encapsulated tablets plus one placebo budesonide tablet, or 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
510 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: budesonide-MMX® 6 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
2: budesonide-MMX® 9 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
3: Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
4: Asacol® 400 mg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Blood sampling, endoscopy
Intervention Description
Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
Intervention Type
Drug
Intervention Name(s)
budesonide-MMX® 6 mg
Intervention Description
6 mg/day, 6 mg tablets
Intervention Type
Drug
Intervention Name(s)
budesonide-MMX® 9 mg
Intervention Description
9 mg/day, 9 mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Asacol® 400 mg
Intervention Description
2400 mg/day, 400 mg tablets
Primary Outcome Measure Information:
Title
Clinical and Endoscopic Remission.
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Clinical Improvement.
Description
Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.
Time Frame
8 weeks
Title
Endoscopic Improvement
Description
Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8. As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Eric Sands
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santarus Clinical Investigational Site 5051
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Santarus Clinical Investigational Site 5102
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36606
Country
United States
Facility Name
Santarus Clinical Investigational Site 5014
City
Sylacauga
State/Province
Alabama
ZIP/Postal Code
35150
Country
United States
Facility Name
Santarus Clinical Investigational Site 5088
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Santarus Clinical Investigational Site 5044
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Santarus Clinical Investigational Site 5099
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Santarus Clinical Investigational Site 5075
City
Fremont
State/Province
California
ZIP/Postal Code
94536
Country
United States
Facility Name
Santarus Clinical Investigational Site 5087
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
Santarus Clinical Investigational Site 5033
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Santarus Clinical Investigational Site 5070
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Santarus Clinical Investigational Site 5067
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Santarus Clinical Investigational Site 5028
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Santarus Clinical Investigational Site 5089
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Santarus Clinical Investigational Site 5041
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Santarus Clinical Investigational Site 5055
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Santarus Clinical Investigational Site 5074
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Santarus Clinical Investigational Site 5032
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Santarus Clinical Investigational Site 5009
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Santarus Clinical Investigational Site 5110
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Santarus Clinical Investigational Site 5047
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Santarus Clinical Investigational Site 5003
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Santarus Clinical Investigational Site 5016
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Santarus Clinical Investigational Site 5056
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Santarus Clinical Investigational Site 5103
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Santarus Clinical Investigational Site 5085
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
Facility Name
Santarus Clinical Investigational Site 5068
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Santarus Clinical Investigational Site 5086
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Santarus Clinical Investigational Site 5053
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Santarus Clinical Investigational Site 5008
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Santarus Clinical Investigational Site 5090
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Santarus Clinical Investigational Site 5025
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Santarus Clinical Investigational Site 5092
City
Hollywood
State/Province
Maryland
ZIP/Postal Code
20636
Country
United States
Facility Name
Santarus Clinical Investigational Site 5077
City
Prince Frederick
State/Province
Maryland
ZIP/Postal Code
20678
Country
United States
Facility Name
Santarus Clinical Investigational Site 5046
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Santarus Clinical Investigational Site 5115
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Santarus Clinical Investigational Site 5010
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Santarus Clinical Investigational Site 5006
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Santarus Clinical Investigational Site 5004
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Santarus Clinical Investigational Site 5105
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Santarus Clinical Investigational Site 5094
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Santarus Clinical Investigational Site 5005
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Santarus Clinical Investigational Site 5024
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
Santarus Clinical Investigational Site 5011
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Santarus Clinical Investigational Site 5101
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Santarus Clinical Investigational Site 5020
City
Pittsford
State/Province
New York
ZIP/Postal Code
14534
Country
United States
Facility Name
Santarus Clinical Investigational Site 5096
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Santarus Clinical Investigational Site 5058
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Santarus Clinical Investigational Site 5091
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Santarus Clinical Investigational Site 5124
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Santarus Clinical Investigational Site 5118
City
Canton
State/Province
Ohio
ZIP/Postal Code
44701
Country
United States
Facility Name
Santarus Clinical Investigational Site 5045
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45218
Country
United States
Facility Name
Santarus Clinical Investigational Site 5078
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Santarus Clinical Investigational Site 5120
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Santarus Clinical Investigational Site 5066
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Santarus Clinical Investigational Site 5065
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
Santarus Clinical Investigational Site 5035
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Santarus Clinical Investigational Site 5107
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Santarus Clinical Investigational Site 5130
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Santarus Clinical Investigational Site 5095
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Santarus Clinical Investigational Site 5021
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Santarus Clinical Investigational Site 5076
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Santarus Clinical Investigational Site 5108
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Santarus Clinical Investigational Site 5019
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Santarus Clinical Investigational Site 5036
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Santarus Clinical Investigational Site 5063
City
Irving
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
Facility Name
Santarus Clinical Investigational Site 5072
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Facility Name
Santarus Clinical Investigational Site 5054
City
La Porte
State/Province
Texas
ZIP/Postal Code
77571
Country
United States
Facility Name
Santarus Clinical Investigational Site 5030
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
Facility Name
Santarus Clinical Investigational Site 5093
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Santarus Clinical Investigational Site 5049
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Santarus Clinical Investigational Site 5100
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Santarus Clinical Investigational Site 5079
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Santarus Clinical Investigational Site 5098
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Santarus Clinical Investigational Site 5015
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Santarus Clinical Investigational Site 5097
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Santarus Clinical Investigational Site 5119
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Santarus Clinical Investigational Site 6005
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 3N5
Country
Canada
Facility Name
Santarus Clinical Investigational Site 6000
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
Facility Name
Santarus Clinical Investigational Site 6014
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Santarus Clinical Investigational Site 6008
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
Santarus Clinical Investigational Site 6004
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 3P8
Country
Canada
Facility Name
Santarus Clinical Investigational Site 6017
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3N5
Country
Canada
Facility Name
Santarus Clinical Investigational Site 6001
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Santarus Clinical Investigational Site 6016
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Santarus Clinical Investigational Site 6002
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Santarus Clinical Investigational Site 6006
City
Toronto
ZIP/Postal Code
M3N 2V7
Country
Canada
Facility Name
Santarus Clinical Investigational Site 9001
City
Andhra Pradesh
Country
India
Facility Name
Santarus Clinical Investigational Site 9009
City
Andhra Pradesh
Country
India
Facility Name
Santarus Clinical Investigational Site 9012
City
Andhra Pradesh
Country
India
Facility Name
Santarus Clinical Investigational Site 9016
City
Andhra Pradesh
Country
India
Facility Name
Santarus Clinical Investigational Site 9006
City
Assam
Country
India
Facility Name
Santarus Clinical Investigational Site 9007
City
Gujarat
Country
India
Facility Name
Santarus Clinical Investigational Site 9004
City
Karnataka
Country
India
Facility Name
Santarus Clinical Investigational Site 9015
City
Karnataka
Country
India
Facility Name
Santarus Clinical Investigational Site 9003
City
Kerala
Country
India
Facility Name
Santarus Clinical Investigational Site 9002
City
Maharashtra
Country
India
Facility Name
Santarus Clinical Investigational Site 9008
City
Maharashtra
Country
India
Facility Name
Santarus Clinical Investigational Site 9010
City
Maharashtra
Country
India
Facility Name
Santarus Clinical Investigational Site 9011
City
Maharashtra
Country
India
Facility Name
Santarus Clinical Investigational Site 9013
City
Maharashtra
Country
India
Facility Name
Santarus Clinical Investigational Site 9017
City
Maharashtra
Country
India
Facility Name
Santarus Clinical Investigational Site 9018
City
Rajasthan
Country
India
Facility Name
Santarus Clinical Investigational Site 9005
City
Tamil Nadu
Country
India
Facility Name
Santarus Clinical Investigational Site 9014
City
Uttar Pradesh
Country
India
Facility Name
Santarus Clinical Investigational Site 7000
City
Colonia Centra
State/Province
La Paz Baja California Sur
ZIP/Postal Code
23000
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
22892337
Citation
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.
Results Reference
result

Learn more about this trial

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

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