Extension Study of Budesonide MMX™ 6mg in Maintenance Of Remission In Patients With Ulcerative Colitis - Full Text View

Sponsor:	Santarus
Information provided by:	Santarus
ClinicalTrials.gov Identifier:	NCT00801723

Purpose

This will be a randomised, double-blind, comparative study versus placebo performed in patients from studies CB-01-02/01 and CB-01-02/02 who achieved UCDAI remission after 8 weeks of treatment.

Patients in remission at the End of Study visit in studies CB-01-02/01 and CB 01 02/02 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 CB-01-02/01 and CB 01 02/02 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 MMXTM 6 mg or placebo irrespective of the treatment assigned in studies CB-01-02/01 and CB 01 02/02. 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.

Condition	Intervention	Phase
Ulcerative Colitis	Procedure: Blood sampling, DXA scan and Synachten® short test	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomised, Double-Blind, Multi-Centre, 12 Month Extension Study To Evaluate The Safety And Efficacy of Daily Budesonide MMX™ 6mg VS Placebo In The Maintenance Of Remission In Subjects With Ulcerative Colitis.

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Bowel Movement Nuclear Scans Ulcerative Colitis

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by Santarus:

Primary Outcome Measures:

The primary efficacy endpoint is the percentage of patients achieving clinical remission at 1, 3, 6, 9 and 12 months, where clinical remission is defined as the combined absence of recurrence of rectal bleeding and absence of increased stool frequency [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to clinical relapse [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
Percentage of patients in UCDAI remission at 12 months [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	December 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Procedure: Blood sampling, DXA scan and Synachten® short test Blood sampling for hematology and biochemistry, DXA scan to assess patient bone loss and Synachten® short test to evaluate patient hypothalmic pituitary-adrenal axis cortisol.
Placebo Comparator: 2: Placebo One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.	Procedure: Blood sampling, DXA scan and Synachten® short test Blood sampling for hematology and biochemistry, DXA scan to assess patient bone loss and Synachten® short test to evaluate patient hypothalmic pituitary-adrenal axis cortisol.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 and CB-01-02/02 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 and CB 01 02/02.
- Subjects who did not achieve induction of remission according to the primary endpoint definition in studies CB-01-02/01 and CB 01 02/02 (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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801723

Show 58 Study Locations

Sponsors and Collaborators

Santarus

Investigators

Principal Investigator:	Bruce Eric Sands	Massachusetts General Hospital
Principal Investigator:	Simon Travis	John Radcliffe Hospital

More Information

No publications provided

Responsible Party:	Maria Bedoya-Toro, PH.D., MBA, VP RA/QA, Santarus Inc.
ClinicalTrials.gov Identifier:	NCT00801723 History of Changes
Other Study ID Numbers:	CB-01-02/04
Study First Received:	December 2, 2008
Last Updated:	February 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Santarus:

Ulcerative Colitis

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Budesonide
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012