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

Ulcerative Colitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801723
• Other study ID #: CB-01-02/04
• Status: Completed
• Phase: Phase 3
• Start date: December 2008
• Est. completion date: June 2011

Study information

• Verified date: August 2020
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Budesonide MMX 6 mg Tablet
Budesonide MMX 6 mg Tablet once daily.
• Placebo Tablet
Placebo Tablet once daily.

Locations

Country	Name	City	State
Canada	Santarus Clinical Investigational Site 6013	Longueuil	Quebec
Canada	Santarus Clinical Investigational Site 6004	Richmond Hill	Ontario
Canada	Santarus Clinical Investigational Site 6006	Toronto	Ontario
Canada	Santarus Clinical Investigational Site 6014	Vancouver	British Columbia
Canada	Santarus Clinical Investigational Site 6008	Victoria	British Columbia
United States	Santarus Clinical Investigational Site 5044	Anaheim	California
United States	Santarus Clinical Investigational Site 5090	Annapolis	Maryland
United States	Santarus Clinical Investigational Site 5016	Atlanta	Georgia
United States	Santarus Clinical Investigational Site 5021	Austin	Texas
United States	Santarus Clinical Investigational Site 5025	Baltimore	Maryland
United States	Santarus Clinical Investigational Site 5089	Boynton Beach	Florida
United States	Santarus Clinical Investigational Site 5010	Chesterfield	Michigan
United States	Santarus Clinical Investigational Site 5097	Christiansburg	Virginia
United States	Santarus Clinical Investigational Site 5045	Cincinnati	Ohio
United States	Santarus Clinical Investigational Site 5056	Columbus	Georgia
United States	Santarus Clinical Investigational Site 5078	Dayton	Ohio
United States	Santarus Clinical Investigational Site 5066	Duncansville	Pennsylvania
United States	Santarus Clinical Investigational Site 5068	Evanston	Illinois
United States	Santarus Clinical Investigational Site 5096	Fayetteville	North Carolina
United States	Santarus Clinical Investigational Site 5011	Great Neck	New York
United States	Santarus Clinical Investigational Site 5041	Hollywood	Florida
United States	Santarus Clinical Investigational Site 5092	Hollywood	Maryland
United States	Santarus Clinical Investigational Site 5019	Houston	Texas
United States	Santarus Clinical Investigational Site 5036	Houston	Texas
United States	Santarus Clinical Investigational Site 5076	Houston	Texas
United States	Santarus Clinical Investigational Site 5058	Huntersville	North Carolina
United States	Santarus Clinical Investigational Site 5051	Huntsville	Alabama
United States	Santarus Clinical Investigational Site 5063	Irving	Texas
United States	Santarus Clinical Investigational Site 5072	Kingwood	Texas
United States	Santarus Clinical Investigational Site 5054	La Porte	Texas
United States	Santarus Clinical Investigational Site 5064	Lakewood	Colorado
United States	Santarus Clinical Investigational Site 5087	Lakewood	California
United States	Santarus Clinical Investigational Site 5030	Lewisville	Texas
United States	Santarus Clinical Investigational Site 5033	Los Angeles	California
United States	Santarus Clinical Investigational Site 5005	Marlton	New Jersey
United States	Santarus Clinical Investigational Site 5008	Metairie	Louisiana
United States	Santarus Clinical Investigational Site 5091	New Bern	North Carolina
United States	Santarus Clinical Investigational Site 5055	New Smyrna Beach	Florida
United States	Santarus Clinical Investigational Site 5101	New York	New York
United States	Santarus Clinical Investigational Site 5070	Palm Springs	California
United States	Santarus Clinical Investigational Site 5020	Pittsford	New York
United States	Santarus Clinical Investigational Site 5093	Plano	Texas
United States	Santarus Clinical Investigational Site 5074	Port Orange	Florida
United States	Santarus Clinical Investigational Site 5065	Pottstown	Pennsylvania
United States	Santarus Clinical Investigational Site 5077	Prince Frederick	Maryland
United States	Santarus Clinical Investigational Site 5015	Salt Lake City	Utah
United States	Santarus Clinical Investigational Site 5079	San Antonio	Texas
United States	Santarus Clinical Investigational Site 5100	San Antonio	Texas
United States	Santarus Clinical Investigational Site 5067	San Diego	California
United States	Santarus Clinical Investigational Site 5035	Sayre	Pennsylvania
United States	Santarus Clinical Investigational Site 5009	Tampa	Florida
United States	Santarus Clinical Investigational Site 5032	Tampa	Florida
United States	Santarus Clinical Investigational Site 5006	Troy	Michigan
United States	Santarus Clinical Investigational Site 5088	Tucson	Arizona
United States	Santarus Clinical Investigational Site 5047	Winter Park	Florida
United States	Santarus Clinical Investigational Site 5004	Wyoming	Michigan
United States	Santarus Clinical Investigational Site 5001	Yukon	Oklahoma
United States	Santarus Clinical Investigational Site 5003	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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