Clinical trial NCT00801723: (CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-03
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Percentage of Participants Achieving Clinical Remission
timeFrame: 1, 3, 6, 9, and 12 months
Secondary outcomes:
measure: Percentage of Participants With Clinical Relapse
timeFrame: 12 months
measure: Percentage of Participants With Endoscopic Relapse
timeFrame: 12 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Santarus Clinical Investigational Site 5051
state: Alabama
city: Tucson
country: United States
facility: Santarus Clinical Investigational Site 5088
state: Arizona
city: Anaheim
country: United States
facility: Santarus Clinical Investigational Site 5044
state: California
city: Lakewood
country: United States
facility: Santarus Clinical Investigational Site 5087
state: California
city: Los Angeles
country: United States
facility: Santarus Clinical Investigational Site 5033
state: California
city: Palm Springs
country: United States
facility: Santarus Clinical Investigational Site 5070
state: California
city: San Diego
country: United States
facility: Santarus Clinical Investigational Site 5067
state: California
city: Lakewood
country: United States
facility: Santarus Clinical Investigational Site 5064
state: Colorado
city: Boynton Beach
country: United States
facility: Santarus Clinical Investigational Site 5089
state: Florida
city: Hollywood
country: United States
facility: Santarus Clinical Investigational Site 5041
state: Florida
city: New Smyrna Beach
country: United States
facility: Santarus Clinical Investigational Site 5055
state: Florida
city: Port Orange
country: United States
facility: Santarus Clinical Investigational Site 5074
state: Florida
city: Tampa
country: United States
facility: Santarus Clinical Investigational Site 5032
state: Florida
city: Tampa
country: United States
facility: Santarus Clinical Investigational Site 5009
state: Florida
city: Winter Park
country: United States
facility: Santarus Clinical Investigational Site 5047
state: Florida
city: Zephyrhills
country: United States
facility: Santarus Clinical Investigational Site 5003
state: Florida
city: Atlanta
country: United States
facility: Santarus Clinical Investigational Site 5016
state: Georgia
city: Columbus
country: United States
facility: Santarus Clinical Investigational Site 5056
state: Georgia
city: Evanston
country: United States
facility: Santarus Clinical Investigational Site 5068
state: Illinois
city: Metairie
country: United States
facility: Santarus Clinical Investigational Site 5008
state: Louisiana
city: Annapolis
country: United States
facility: Santarus Clinical Investigational Site 5090
state: Maryland
city: Baltimore
country: United States
facility: Santarus Clinical Investigational Site 5025
state: Maryland
city: Hollywood
country: United States
facility: Santarus Clinical Investigational Site 5092
state: Maryland
city: Prince Frederick
country: United States
facility: Santarus Clinical Investigational Site 5077
state: Maryland
city: Chesterfield
country: United States
facility: Santarus Clinical Investigational Site 5010
state: Michigan
city: Troy
country: United States
facility: Santarus Clinical Investigational Site 5006
state: Michigan
city: Wyoming
country: United States
facility: Santarus Clinical Investigational Site 5004
state: Michigan
city: Marlton
country: United States
facility: Santarus Clinical Investigational Site 5005
state: New Jersey
city: Great Neck
country: United States
facility: Santarus Clinical Investigational Site 5011
state: New York
city: New York
country: United States
facility: Santarus Clinical Investigational Site 5101
state: New York
city: Pittsford
country: United States
facility: Santarus Clinical Investigational Site 5020
state: New York
city: Fayetteville
country: United States
facility: Santarus Clinical Investigational Site 5096
state: North Carolina
city: Huntersville
country: United States
facility: Santarus Clinical Investigational Site 5058
state: North Carolina
city: New Bern
country: United States
facility: Santarus Clinical Investigational Site 5091
state: North Carolina
city: Cincinnati
country: United States
facility: Santarus Clinical Investigational Site 5045
state: Ohio
city: Dayton
country: United States
facility: Santarus Clinical Investigational Site 5078
state: Ohio
city: Yukon
country: United States
facility: Santarus Clinical Investigational Site 5001
state: Oklahoma
city: Duncansville
country: United States
facility: Santarus Clinical Investigational Site 5066
state: Pennsylvania
city: Pottstown
country: United States
facility: Santarus Clinical Investigational Site 5065
state: Pennsylvania
city: Sayre
country: United States
facility: Santarus Clinical Investigational Site 5035
state: Pennsylvania
city: Austin
country: United States
facility: Santarus Clinical Investigational Site 5021
state: Texas
city: Houston
country: United States
facility: Santarus Clinical Investigational Site 5076
state: Texas
city: Houston
country: United States
facility: Santarus Clinical Investigational Site 5019
state: Texas
city: Houston
country: United States
facility: Santarus Clinical Investigational Site 5036
state: Texas
city: Irving
country: United States
facility: Santarus Clinical Investigational Site 5063
state: Texas
city: Kingwood
country: United States
facility: Santarus Clinical Investigational Site 5072
state: Texas
city: La Porte
country: United States
facility: Santarus Clinical Investigational Site 5054
state: Texas
city: Lewisville
country: United States
facility: Santarus Clinical Investigational Site 5030
state: Texas
city: Plano
country: United States
facility: Santarus Clinical Investigational Site 5093
state: Texas
city: San Antonio
country: United States
facility: Santarus Clinical Investigational Site 5100
state: Texas
city: San Antonio
country: United States
facility: Santarus Clinical Investigational Site 5079
state: Texas
city: Salt Lake City
country: United States
facility: Santarus Clinical Investigational Site 5015
state: Utah
city: Christiansburg
country: United States
facility: Santarus Clinical Investigational Site 5097
state: Virginia
city: Vancouver
country: Canada
facility: Santarus Clinical Investigational Site 6014
state: British Columbia
city: Victoria
country: Canada
facility: Santarus Clinical Investigational Site 6008
state: British Columbia
city: Richmond Hill
country: Canada
facility: Santarus Clinical Investigational Site 6004
state: Ontario
city: Toronto
country: Canada
facility: Santarus Clinical Investigational Site 6006
state: Ontario
city: Longueuil
country: Canada
facility: Santarus Clinical Investigational Site 6013
state: Quebec
Study officials:
affiliation: Massachusetts General Hospital
name: Bruce Eric Sands
role: PRINCIPAL_INVESTIGATOR
affiliation: Oxford University Hospitals NHS Trust
name: Simon Travis
role: PRINCIPAL_INVESTIGATOR
References: