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Sponsored by: |
Santarus |
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Information provided by: | Santarus |
ClinicalTrials.gov Identifier: | NCT00679432 |
The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.
Condition | Intervention | Phase |
---|---|---|
Ulcerative Colitis |
Procedure: Blood sampling, endoscopy Drug: Budesonide-MMX Drug: Asacol Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg. |
Estimated Enrollment: | 492 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Budesonide-MMX™ 6 mg
|
Procedure: Blood sampling, endoscopy
Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
Drug: Budesonide-MMX
Budesonide-MMX™ 6mg or 9 mg
|
2: Experimental
Budesonide-MMX™ 9 mg
|
Procedure: Blood sampling, endoscopy
Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
Drug: Budesonide-MMX
Budesonide-MMX™ 6mg or 9 mg
|
3: Placebo Comparator |
Procedure: Blood sampling, endoscopy
Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
Drug: Placebo
Placebo
|
4: Active Comparator
Asacol® 400 mg
|
Procedure: Blood sampling, endoscopy
Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
Drug: Asacol
Asacol® 400 mg
|
Each patient will receive one of the following regimens in the morning after breakfast:
Each patient will also receive on each day after the midday meal and after the evening meal either:
Hence, each patient is to take seven tablets per day of active or placebo study medication as per the randomization schedule. Placebo tablets of budesonide-MMX™ and placebo over-encapsulated tablets of Asacol® will be used to maintain the study blind using a double-dummy technique.
During the study, five visits to the clinical center are scheduled: one at Screening and three in the double-blind treatment period (Day 1, Day 14, Day 28 and Day 56). A safety follow up visit will take place about 2 weeks after the final study visit. If a patient is withdrawn from the study before Day 56, they will be asked to attend the study center as soon as possible thereafter so that the Final visit assessments can be conducted.
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 at the screening visit are eligible for participation in the study:
Exclusion Criteria:
Patients who meet any of the following criteria at screening visit are to be excluded from study participation:
Contact: Lisa Villicana | (215) 616-3424 | VillicanaL@iconus.com |
Principal Investigator: | Bruce Eric Sands | Massachusetts General Hospital |
Responsible Party: | ICON Clinical Research ( Lisa Villicana/ Clinical Project Manager ) |
Study ID Numbers: | CB-01-02/01 |
Study First Received: | May 14, 2008 |
Last Updated: | August 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00679432 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Ulcerative colitis |
Anti-Inflammatory Agents Gastrointestinal Diseases Mesalamine Hormone Antagonists Ulcer Colonic Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases |
Hormones Glucocorticoids Digestive System Diseases Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Gastroenteritis Colitis Bronchodilator Agents |
Anti-Inflammatory Agents Respiratory System Agents Gastrointestinal Diseases Colonic Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Inflammatory Bowel Diseases Hormones Pathologic Processes Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Mesalamine Ulcer |
Budesonide Anti-Asthmatic Agents Colitis, Ulcerative Intestinal Diseases Glucocorticoids Pharmacologic Actions Digestive System Diseases Analgesics, Non-Narcotic Autonomic Agents Peripheral Nervous System Agents Antirheumatic Agents Gastroenteritis Central Nervous System Agents Bronchodilator Agents Colitis |