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

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: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Budesonide MMX 6 mg Tablet; Drug: Placebo Tablet

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	1, 3, 6, 9, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Principal Investigator: Simon Travis, Oxford University Hospitals NHS Trust; Principal Investigator: Bruce Eric Sands, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 2, 2008
• First Submitted That Met QC Criteria: December 2, 2008
• First Posted (Estimate): December 3, 2008

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Ulcerative Colitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: CB-01-02/04