(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.

August 14, 2020 updated by: Bausch Health Americas, Inc.

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Santarus Clinical Investigational Site 6014
      • Victoria, British Columbia, Canada, V8R 1J8
        • Santarus Clinical Investigational Site 6008
    • Ontario
      • Richmond Hill, Ontario, Canada, L4B 3P8
        • Santarus Clinical Investigational Site 6004
      • Toronto, Ontario, Canada, M3N 2V7
        • Santarus Clinical Investigational Site 6006
    • Quebec
      • Longueuil, Quebec, Canada, J4N 1E1
        • Santarus Clinical Investigational Site 6013
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Santarus Clinical Investigational Site 5051
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Santarus Clinical Investigational Site 5088
    • California
      • Anaheim, California, United States, 92801
        • Santarus Clinical Investigational Site 5044
      • Lakewood, California, United States, 90712
        • Santarus Clinical Investigational Site 5087
      • Los Angeles, California, United States, 90045
        • Santarus Clinical Investigational Site 5033
      • Palm Springs, California, United States, 92262
        • Santarus Clinical Investigational Site 5070
      • San Diego, California, United States, 92101
        • Santarus Clinical Investigational Site 5067
    • Colorado
      • Lakewood, Colorado, United States, 80215
        • Santarus Clinical Investigational Site 5064
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Santarus Clinical Investigational Site 5089
      • Hollywood, Florida, United States, 33021
        • Santarus Clinical Investigational Site 5041
      • New Smyrna Beach, Florida, United States, 32168
        • Santarus Clinical Investigational Site 5055
      • Port Orange, Florida, United States, 32127
        • Santarus Clinical Investigational Site 5074
      • Tampa, Florida, United States, 33607
        • Santarus Clinical Investigational Site 5032
      • Tampa, Florida, United States, 33613
        • Santarus Clinical Investigational Site 5009
      • Winter Park, Florida, United States, 32789
        • Santarus Clinical Investigational Site 5047
      • Zephyrhills, Florida, United States, 33542
        • Santarus Clinical Investigational Site 5003
    • Georgia
      • Atlanta, Georgia, United States, 30312
        • Santarus Clinical Investigational Site 5016
      • Columbus, Georgia, United States, 31904
        • Santarus Clinical Investigational Site 5056
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Santarus Clinical Investigational Site 5068
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Santarus Clinical Investigational Site 5008
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Santarus Clinical Investigational Site 5090
      • Baltimore, Maryland, United States, 21229
        • Santarus Clinical Investigational Site 5025
      • Hollywood, Maryland, United States, 20636
        • Santarus Clinical Investigational Site 5092
      • Prince Frederick, Maryland, United States, 20678
        • Santarus Clinical Investigational Site 5077
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Santarus Clinical Investigational Site 5010
      • Troy, Michigan, United States, 48098
        • Santarus Clinical Investigational Site 5006
      • Wyoming, Michigan, United States, 49519
        • Santarus Clinical Investigational Site 5004
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Santarus Clinical Investigational Site 5005
    • New York
      • Great Neck, New York, United States, 11021
        • Santarus Clinical Investigational Site 5011
      • New York, New York, United States, 10016
        • Santarus Clinical Investigational Site 5101
      • Pittsford, New York, United States, 14534
        • Santarus Clinical Investigational Site 5020
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Santarus Clinical Investigational Site 5096
      • Huntersville, North Carolina, United States, 28078
        • Santarus Clinical Investigational Site 5058
      • New Bern, North Carolina, United States, 28562
        • Santarus Clinical Investigational Site 5091
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Santarus Clinical Investigational Site 5045
      • Dayton, Ohio, United States, 45440
        • Santarus Clinical Investigational Site 5078
    • Oklahoma
      • Yukon, Oklahoma, United States, 73099
        • Santarus Clinical Investigational Site 5001
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Santarus Clinical Investigational Site 5066
      • Pottstown, Pennsylvania, United States, 19464
        • Santarus Clinical Investigational Site 5065
      • Sayre, Pennsylvania, United States, 18840
        • Santarus Clinical Investigational Site 5035
    • Texas
      • Austin, Texas, United States, 78745
        • Santarus Clinical Investigational Site 5021
      • Houston, Texas, United States, 77034
        • Santarus Clinical Investigational Site 5076
      • Houston, Texas, United States, 77090
        • Santarus Clinical Investigational Site 5019
      • Houston, Texas, United States, 77090
        • Santarus Clinical Investigational Site 5036
      • Irving, Texas, United States, 75061
        • Santarus Clinical Investigational Site 5063
      • Kingwood, Texas, United States, 77339
        • Santarus Clinical Investigational Site 5072
      • La Porte, Texas, United States, 77571
        • Santarus Clinical Investigational Site 5054
      • Lewisville, Texas, United States, 75057
        • Santarus Clinical Investigational Site 5030
      • Plano, Texas, United States, 75075
        • Santarus Clinical Investigational Site 5093
      • San Antonio, Texas, United States, 78229
        • Santarus Clinical Investigational Site 5100
      • San Antonio, Texas, United States, 78258
        • Santarus Clinical Investigational Site 5079
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Santarus Clinical Investigational Site 5015
    • Virginia
      • Christiansburg, Virginia, United States, 24073
        • Santarus Clinical Investigational Site 5097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1: Budesonide MMX® 6 mg
One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Drug: Budesonide MMX 6 mg Tablet
Budesonide MMX 6 mg Tablet once daily.
Placebo Comparator: 2: Placebo
One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Drug: Placebo Tablet
Placebo Tablet once daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Clinical Remission
Time Frame: 1, 3, 6, 9, and 12 months
Clinical remission was defined as the combined absence of recurrence of rectal bleeding and absence of increased stool frequency.
1, 3, 6, 9, and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinical Relapse
Time Frame: 12 months
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.
12 months
Percentage of Participants With Endoscopic Relapse
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bausch Health Americas, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Simon Travis, Oxford University Hospitals NHS Trust
  • Principal Investigator: Bruce Eric Sands, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CB-01-02/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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