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Ulcerative ColitisPhase 3NCT00801723

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

A Phase 3 study testing Budesonide MMX 6 mg Tablet in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 58 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Budesonide MMX 6 mg Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
123 participants
Where
58 sitesin 2 countries
Study dates
Dec 2008to Jun 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

58 sites in 2 countries.

58 sites in 2 countries

United States53 sites

  • Santarus Clinical Investigational Site 5044

    Anaheim, California, 92801

  • Santarus Clinical Investigational Site 5090

    Annapolis, Maryland, 21401

  • Santarus Clinical Investigational Site 5016

    Atlanta, Georgia, 30312

  • Santarus Clinical Investigational Site 5021

    Austin, Texas, 78745

  • Santarus Clinical Investigational Site 5025

    Baltimore, Maryland, 21229

  • Santarus Clinical Investigational Site 5089

    Boynton Beach, Florida, 33426

  • Santarus Clinical Investigational Site 5010

    Chesterfield, Michigan, 48047

  • Santarus Clinical Investigational Site 5097

    Christiansburg, Virginia, 24073

  • Santarus Clinical Investigational Site 5045

    Cincinnati, Ohio, 45219

  • Santarus Clinical Investigational Site 5056

    Columbus, Georgia, 31904

  • Santarus Clinical Investigational Site 5078

    Dayton, Ohio, 45440

  • Santarus Clinical Investigational Site 5066

    Duncansville, Pennsylvania, 16635

  • Santarus Clinical Investigational Site 5068

    Evanston, Illinois, 60201

  • Santarus Clinical Investigational Site 5096

    Fayetteville, North Carolina, 28304

  • Santarus Clinical Investigational Site 5011

    Great Neck, New York, 11021

  • Santarus Clinical Investigational Site 5041

    Hollywood, Florida, 33021

  • Santarus Clinical Investigational Site 5092

    Hollywood, Maryland, 20636

  • Santarus Clinical Investigational Site 5076

    Houston, Texas, 77034

  • Santarus Clinical Investigational Site 5019

    Houston, Texas, 77090

  • Santarus Clinical Investigational Site 5036

    Houston, Texas, 77090

  • Santarus Clinical Investigational Site 5058

    Huntersville, North Carolina, 28078

  • Santarus Clinical Investigational Site 5051

    Huntsville, Alabama, 35801

  • Santarus Clinical Investigational Site 5063

    Irving, Texas, 75061

  • Santarus Clinical Investigational Site 5072

    Kingwood, Texas, 77339

  • Santarus Clinical Investigational Site 5054

    La Porte, Texas, 77571

  • Santarus Clinical Investigational Site 5087

    Lakewood, California, 90712

  • Santarus Clinical Investigational Site 5064

    Lakewood, Colorado, 80215

  • Santarus Clinical Investigational Site 5030

    Lewisville, Texas, 75057

  • Santarus Clinical Investigational Site 5033

    Los Angeles, California, 90045

  • Santarus Clinical Investigational Site 5005

    Marlton, New Jersey, 08053

  • Santarus Clinical Investigational Site 5008

    Metairie, Louisiana, 70006

  • Santarus Clinical Investigational Site 5091

    New Bern, North Carolina, 28562

  • Santarus Clinical Investigational Site 5055

    New Smyrna Beach, Florida, 32168

  • Santarus Clinical Investigational Site 5101

    New York, New York, 10016

  • Santarus Clinical Investigational Site 5070

    Palm Springs, California, 92262

  • Santarus Clinical Investigational Site 5020

    Pittsford, New York, 14534

  • Santarus Clinical Investigational Site 5093

    Plano, Texas, 75075

  • Santarus Clinical Investigational Site 5074

    Port Orange, Florida, 32127

  • Santarus Clinical Investigational Site 5065

    Pottstown, Pennsylvania, 19464

  • Santarus Clinical Investigational Site 5077

    Prince Frederick, Maryland, 20678

  • Santarus Clinical Investigational Site 5015

    Salt Lake City, Utah, 84107

  • Santarus Clinical Investigational Site 5100

    San Antonio, Texas, 78229

  • Santarus Clinical Investigational Site 5079

    San Antonio, Texas, 78258

  • Santarus Clinical Investigational Site 5067

    San Diego, California, 92101

  • Santarus Clinical Investigational Site 5035

    Sayre, Pennsylvania, 18840

  • Santarus Clinical Investigational Site 5032

    Tampa, Florida, 33607

  • Santarus Clinical Investigational Site 5009

    Tampa, Florida, 33613

  • Santarus Clinical Investigational Site 5006

    Troy, Michigan, 48098

  • Santarus Clinical Investigational Site 5088

    Tucson, Arizona, 85712

  • Santarus Clinical Investigational Site 5047

    Winter Park, Florida, 32789

  • Santarus Clinical Investigational Site 5004

    Wyoming, Michigan, 49519

  • Santarus Clinical Investigational Site 5001

    Yukon, Oklahoma, 73099

  • Santarus Clinical Investigational Site 5003

    Zephyrhills, Florida, 33542

Other trials in United States

Canada5 sites

  • Santarus Clinical Investigational Site 6013

    Longueuil, Quebec, J4N 1E1

  • Santarus Clinical Investigational Site 6004

    Richmond Hill, Ontario, L4B 3P8

  • Santarus Clinical Investigational Site 6006

    Toronto, Ontario, M3N 2V7

  • Santarus Clinical Investigational Site 6014

    Vancouver, British Columbia, V6Z 2K5

  • Santarus Clinical Investigational Site 6008

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

About this study

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.

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.

Read more

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.

Being tested
Budesonide MMX 6 mg Tablet, Placebo Tablet
Keywords
Ulcerative Colitis
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Budesonide MMX 6 mg TabletDrug

    Budesonide MMX 6 mg Tablet once daily.

  • Placebo TabletDrug

    Placebo Tablet once daily.

Study groups in NCT00801723
Study groupRoleWhat they receive
1: Budesonide MMX® 6 mgExperimentalOne Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Receives: Drug: Budesonide MMX 6 mg Tablet
2: PlaceboPlacebo comparatorOne placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Receives: Drug: Placebo Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1, 3, 6, 9, and 12 months

Secondary outcomes (2)

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionMay 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00801723
Sponsor's protocol ID
CB-01-02/04
Status last verified
Aug 2020
First submitted
2 Dec 2008
Last updated
31 Aug 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Budesonide MMX 6 mg Tablet in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 58 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Clinical Remission (time frame: 1, 3, 6, 9, and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00801723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.

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