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

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT00801723

Run by

Bausch Health Americas, Inc.

People needed

123

Starts

2008-12-01

Expected to finish

2011-06-01

Last updated by the study team

2020-08-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Santarus Clinical Investigational Site 5088 — Tucson, Arizona, United States
• Santarus Clinical Investigational Site 5044 — Anaheim, California, United States
• Santarus Clinical Investigational Site 5087 — Lakewood, California, United States
• Santarus Clinical Investigational Site 5033 — Los Angeles, California, United States
• Santarus Clinical Investigational Site 5070 — Palm Springs, California, United States
• Santarus Clinical Investigational Site 5067 — San Diego, California, United States
• Santarus Clinical Investigational Site 5064 — Lakewood, Colorado, United States
• Santarus Clinical Investigational Site 5089 — Boynton Beach, Florida, United States
• Santarus Clinical Investigational Site 5041 — Hollywood, Florida, United States
• Santarus Clinical Investigational Site 5055 — New Smyrna Beach, Florida, United States
• Santarus Clinical Investigational Site 5074 — Port Orange, Florida, United States
• Santarus Clinical Investigational Site 5032 — Tampa, Florida, United States
• Santarus Clinical Investigational Site 5009 — Tampa, Florida, United States
• Santarus Clinical Investigational Site 5047 — Winter Park, Florida, United States
• Santarus Clinical Investigational Site 5003 — Zephyrhills, Florida, United States
• Santarus Clinical Investigational Site 5016 — Atlanta, Georgia, United States
• Santarus Clinical Investigational Site 5056 — Columbus, Georgia, United States
• Santarus Clinical Investigational Site 5068 — Evanston, Illinois, United States
• Santarus Clinical Investigational Site 5008 — Metairie, Louisiana, United States
• Santarus Clinical Investigational Site 5090 — Annapolis, Maryland, United States
• Santarus Clinical Investigational Site 5025 — Baltimore, Maryland, United States
• Santarus Clinical Investigational Site 5092 — Hollywood, Maryland, United States
• Santarus Clinical Investigational Site 5077 — Prince Frederick, Maryland, United States
• Santarus Clinical Investigational Site 5010 — Chesterfield, Michigan, United States
• Santarus Clinical Investigational Site 5051 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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