(CB-01-02/04) Extension Study of Budesonide MMX™ 6mg in Maintenance Of Remission In Patients With Ulcerative Colitis
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Purpose
Randomized, double-blind, comparative study versus placebo performed in patients from studies CB-01-02/01, CB-01-02/02 and CB-01-02/06 who achieved UCDAI remission after 8 weeks of treatment.
Patients in remission at the End of Study visit were 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 was planned that approximately 150 patients will be enrolled in the study. Patients were randomly assigned to two groups to receive either budesonide MMXTM 6 mg or placebo irrespective of the treatment assigned in studies 01, 02 or 06. Treatments were 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 were assessed for safety and efficacy at Visit 1 and after 1, 3, 6, 9 and 12 months of treatment.
Patients were 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 |
Drug: Budesonide MMX 6 mg Tablet |
Phase 3 |
| 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. |
- 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 ]
- Time to clinical relapse [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
- Endoscopic Relapse [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
| Enrollment: | 150 |
| Study Start Date: | December 2008 |
| Study Completion Date: | June 2011 |
| 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.
|
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: Budesonide MMX 6 mg Tablet
Budesonide MMX 6 mg Tablet once daily.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Show 58 Study Locations| Principal Investigator: | Bruce Eric Sands | Massachusetts General Hospital |
| Principal Investigator: | Simon Travis | John Radcliffe Hospital |
More Information
No publications provided
| Responsible Party: | Santarus |
| ClinicalTrials.gov Identifier: | NCT00801723 History of Changes |
| Other Study ID Numbers: | CB-01-02/04 |
| Study First Received: | December 2, 2008 |
| Last Updated: | May 7, 2013 |
| 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 May 22, 2013