Back to results(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Budesonide MMX 6 mg Tablet
Placebo Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
Patients fulfilling the following criteria are eligible for participation in the study:
- Male and female patients, 18-75 years old, who are able to understand and voluntarily provide written informed consent.
- Patients in UCDAI remission defined as a UCDAI score ≤ 1 point with a score of 0 for rectal bleeding and stool frequency, and a ≥ 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability (score 0 for mucosal appearance).
- Patients who have completed all End of Study assessments for the CB-01-02/01, CB-01-02/02 and CB-01-02/06 studies.
- Females of child-bearing potential must have had a serum pregnancy test performed at the End of Study visit of the parent studies and must use an acceptable contraceptive method throughout the study treatment period.
Exclusion Criteria:
Patients who meet any of the following criteria at screening visit are to be excluded from study participation:
- Subjects who have withdrawn from studies CB-01-02/01, CB 01 02/02 or CB-01-02/06.
- Subjects who did not achieve induction of remission according to the primary endpoint definition in studies CB-01-02/01, CB 01 02/02 or CB-01-02/06 (i.e. clinical remission defined as a UCDAI score ≤ 1 point with a score of 0 for rectal bleeding and stool frequency, and ≥ 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability [score 0 for mucosal appearance]).
- Subjects with bone density lower than normal by age and sex (T-score lower than -1) as assessed via dual energy X-ray absorptiometry (DXA) scans.
Sites / Locations
- Santarus Clinical Investigational Site 5051
- Santarus Clinical Investigational Site 5088
- Santarus Clinical Investigational Site 5044
- Santarus Clinical Investigational Site 5087
- Santarus Clinical Investigational Site 5033
- Santarus Clinical Investigational Site 5070
- Santarus Clinical Investigational Site 5067
- Santarus Clinical Investigational Site 5064
- 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 5047
- Santarus Clinical Investigational Site 5003
- Santarus Clinical Investigational Site 5016
- Santarus Clinical Investigational Site 5056
- Santarus Clinical Investigational Site 5068
- 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 5010
- Santarus Clinical Investigational Site 5006
- Santarus Clinical Investigational Site 5004
- Santarus Clinical Investigational Site 5005
- 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 5045
- Santarus Clinical Investigational Site 5078
- Santarus Clinical Investigational Site 5001
- Santarus Clinical Investigational Site 5066
- Santarus Clinical Investigational Site 5065
- Santarus Clinical Investigational Site 5035
- Santarus Clinical Investigational Site 5021
- Santarus Clinical Investigational Site 5076
- 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 5100
- Santarus Clinical Investigational Site 5079
- Santarus Clinical Investigational Site 5015
- Santarus Clinical Investigational Site 5097
- Santarus Clinical Investigational Site 6014
- Santarus Clinical Investigational Site 6008
- Santarus Clinical Investigational Site 6004
- Santarus Clinical Investigational Site 6006
- Santarus Clinical Investigational Site 6013
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1: Budesonide MMX® 6 mg
2: Placebo
Arm Description
One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.
One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Clinical Remission
Clinical remission was defined as the combined absence of recurrence of rectal bleeding and absence of increased stool frequency.
Secondary Outcome Measures
Percentage of Participants With Clinical Relapse
Clinical relapse was defined as the recurrence of rectal bleeding and/or an abnormal stool frequency [≥ 1-2 stools/day above normal for the participant. Clinical remission/relapse status was based on participant diary entries prior to each scheduled visit.
Percentage of Participants With Endoscopic Relapse
Endoscopic relapse was defined as an increase of ≥ 2 points in the Endoscopic Index score from the value calculated at baseline. The score is comprised of four components (granulated scattering reflected light, vascular pattern, vulnerability of mucosa, and mucosal damage). Scores range from 0 to 12, and higher scores indicate more severe (worse) endoscopic findings.
Full Information
NCT ID
NCT00801723
First Posted
December 2, 2008
Last Updated
August 14, 2020
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00801723
Brief Title
(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
Official Title
Randomised, Double-Blind, Multi-Centre, 12 Month Extension Study to Evaluate the Safety And Efficacy of Daily Budesonide MMX 6 mg Versus Placebo in the Maintenance of Remission in Subjects With Ulcerative Colitis.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (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
Randomized, double-blind, comparative study versus placebo performed in patients from studies CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who achieved ulcerative colitis disease activity index (UCDAI) remission after 8 weeks of treatment.
Patients in remission at the End of Study visit will be given the opportunity to enter the 12-month Maintenance Phase study outlined in this protocol (CB-01-02/04). The End of Study visit in studies 01, 02, and 06 will be set as the Visit 1 (Day 0) of this study. There will be no interruption of study treatment between the parent studies and this study.
It is planned that approximately 150 patients will be enrolled in the study. Patients will be randomly assigned to two groups to receive either budesonide MMX 6 mg or placebo irrespective of the treatment assigned in studies 01, 02, or 06. Treatments will be administered once a day after breakfast for a maximum of 12 months or up to the occurrence of the first clinical relapse, where clinical relapse is defined as combined recurrence of rectal bleeding and stool frequency ≥ 1-2 stools/day above normal for the patient (score ≥ 1 in both UCDAI items).
During the study, patients will be assessed for safety and efficacy at Visit 1 and after 1, 3, 6, 9, and 12 months of treatment.
Patients will be contacted by telephone on a monthly basis for safety assessment. In case of occurrence of symptoms suggestive of clinical relapse, patients will attend an unscheduled visit at any time during the study.
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
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Budesonide MMX® 6 mg
Arm Type
Experimental
Arm Description
One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Arm Title
2: Placebo
Arm Type
Placebo Comparator
Arm Description
One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Intervention Type
Drug
Intervention Name(s)
Budesonide MMX 6 mg Tablet
Intervention Description
Budesonide MMX 6 mg Tablet once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo Tablet
Intervention Description
Placebo Tablet once daily.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Clinical Remission
Description
Clinical remission was defined as the combined absence of recurrence of rectal bleeding and absence of increased stool frequency.
Time Frame
1, 3, 6, 9, and 12 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinical Relapse
Description
Clinical relapse was defined as the recurrence of rectal bleeding and/or an abnormal stool frequency [≥ 1-2 stools/day above normal for the participant. Clinical remission/relapse status was based on participant diary entries prior to each scheduled visit.
Time Frame
12 months
Title
Percentage of Participants With Endoscopic Relapse
Description
Endoscopic relapse was defined as an increase of ≥ 2 points in the Endoscopic Index score from the value calculated at baseline. The score is comprised of four components (granulated scattering reflected light, vascular pattern, vulnerability of mucosa, and mucosal damage). Scores range from 0 to 12, and higher scores indicate more severe (worse) endoscopic findings.
Time Frame
12 months
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 are eligible for participation in the study:
Male and female patients, 18-75 years old, who are able to understand and voluntarily provide written informed consent.
Patients in UCDAI remission defined as a UCDAI score ≤ 1 point with a score of 0 for rectal bleeding and stool frequency, and a ≥ 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability (score 0 for mucosal appearance).
Patients who have completed all End of Study assessments for the CB-01-02/01, CB-01-02/02 and CB-01-02/06 studies.
Females of child-bearing potential must have had a serum pregnancy test performed at the End of Study visit of the parent studies and must use an acceptable contraceptive method throughout the study treatment period.
Exclusion Criteria:
Patients who meet any of the following criteria at screening visit are to be excluded from study participation:
Subjects who have withdrawn from studies CB-01-02/01, CB 01 02/02 or CB-01-02/06.
Subjects who did not achieve induction of remission according to the primary endpoint definition in studies CB-01-02/01, CB 01 02/02 or CB-01-02/06 (i.e. clinical remission defined as a UCDAI score ≤ 1 point with a score of 0 for rectal bleeding and stool frequency, and ≥ 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability [score 0 for mucosal appearance]).
Subjects with bone density lower than normal by age and sex (T-score lower than -1) as assessed via dual energy X-ray absorptiometry (DXA) scans.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Eric Sands
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simon Travis
Organizational Affiliation
Oxford University Hospitals NHS Trust
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 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 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 5064
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
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 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 5068
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
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 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 5005
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
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 5045
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
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 5001
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
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 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 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 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 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 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 6006
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 2V7
Country
Canada
Facility Name
Santarus Clinical Investigational Site 6013
City
Longueuil
State/Province
Quebec
ZIP/Postal Code
J4N 1E1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
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