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

Last updated: August 14, 2020
Sponsor: Bausch Health Americas, Inc.
Overall Status: Completed

Phase

3

Condition

Ulcerative Colitis

Bowel Dysfunction

Ulcers

Treatment

N/A

Clinical Study ID

NCT00801723
CB-01-02/04
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients fulfilling the following criteria are eligible for participation in thestudy:

  • Male and female patients, 18-75 years old, who are able to understand andvoluntarily provide written informed consent.

  • Patients in UCDAI remission defined as a UCDAI score ≤ 1 point with a score of 0for rectal bleeding and stool frequency, and a ≥ 1 point reduction from baselinein the endoscopy score without any sign of mucosal friability (score 0 formucosal 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 performedat the End of Study visit of the parent studies and must use an acceptablecontraceptive method throughout the study treatment period.

Exclusion

Exclusion Criteria:

  • Patients who meet any of the following criteria at screening visit are to be excludedfrom 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 primaryendpoint 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 forrectal bleeding and stool frequency, and ≥ 1 point reduction from baseline in theendoscopy score without any sign of mucosal friability [score 0 for mucosalappearance]).

  • 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 Design

Total Participants: 123
Study Start date:
December 01, 2008
Estimated Completion Date:
June 30, 2011

Connect with a study center

  • Santarus Clinical Investigational Site 6014

    Vancouver, British Columbia V6Z 2K5
    Canada

    Site Not Available

  • Santarus Clinical Investigational Site 6008

    Victoria, British Columbia V8R 1J8
    Canada

    Site Not Available

  • Santarus Clinical Investigational Site 6004

    Richmond Hill, Ontario L4B 3P8
    Canada

    Site Not Available

  • Santarus Clinical Investigational Site 6006

    Toronto, Ontario M3N 2V7
    Canada

    Site Not Available

  • Santarus Clinical Investigational Site 6013

    Longueuil, Quebec J4N 1E1
    Canada

    Site Not Available

  • Santarus Clinical Investigational Site 5051

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5088

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5088

    Tuscon, Arizona 85712
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5044

    Anaheim, California 92801
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5087

    Lakewood, California 90712
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5033

    Los Angeles, California 90045
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5070

    Palm Springs, California 92262
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5067

    San Diego, California 92101
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5064

    Lakewood, Colorado 80215
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5089

    Boynton Beach, Florida 33426
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5041

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5055

    New Smyrna Beach, Florida 32168
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5074

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5009

    Tampa, Florida 33613
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5032

    Tampa, Florida 33607
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5047

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5003

    Zephyrhills, Florida 33542
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5016

    Atlanta, Georgia 30312
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5056

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5068

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5008

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5090

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5025

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5092

    Hollywood, Maryland 20636
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5077

    Prince Frederick, Maryland 20678
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5010

    Chesterfield, Michigan 48047
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5006

    Troy, Michigan 48098
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5004

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5005

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5011

    Great Neck, New York 11021
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5101

    New York, New York 10016
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5020

    Pittsford, New York 14534
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5096

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5058

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5091

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5045

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5078

    Dayton, Ohio 45440
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5001

    Yukon, Oklahoma 73099
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5066

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5065

    Pottstown, Pennsylvania 19464
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5035

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5021

    Austin, Texas 78745
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5019

    Houston, Texas 77090
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5036

    Houston, Texas 77090
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5076

    Houston, Texas 77034
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5063

    Irving, Texas 75061
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5072

    Kingwood, Texas 77339
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5054

    La Porte, Texas 77571
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5054

    LaPort Texas, Texas 77571
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5030

    Lewisville, Texas 75057
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5093

    Plano, Texas 75075
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5079

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5100

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5015

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5097

    Christianburg, Virginia 24073
    United States

    Site Not Available

  • Santarus Clinical Investigational Site 5097

    Christiansburg, Virginia 24073
    United States

    Site Not Available

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