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Sponsored by: |
Cosmo Technologies Ltd |
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Information provided by: | Cosmo Technologies Ltd |
ClinicalTrials.gov Identifier: | NCT00679432 |
This will be a multicentre, randomized, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Asacol® 6 x 400 mg tablets, in four parallel groups of patients over an 8-week treatment period.
After the screening visit, eligible patients will discontinue their current therapy for ulcerative colitis and will undergo a washout period of 2 days prior to the planned first dose of study drug.
Eligible patients will be randomized to one of the following four treatment arms:
Hence, 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:
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 If a patient is withdrawn from the study before Day 56, they will be asked to attend the study center as soon as possible thereafter so that the Final visit assessments can be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.
Condition | Intervention | Phase |
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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: | August 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Budesonide-MMX™ 6 mg
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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
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2: Experimental
Budesonide-MMX™ 9 mg
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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
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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
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4: Active Comparator
Asacol® 400 mg
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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
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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: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00679432 |
Health Authority: | United States: Food and Drug Administration |
Ulcerative colitis |
Digestive System Diseases Mesalamine Gastrointestinal Diseases Ulcer Colonic Diseases Budesonide |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Anti-Inflammatory Agents Respiratory System Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Glucocorticoids Hormones Pharmacologic Actions Pathologic Processes Sensory System Agents |
Analgesics, Non-Narcotic Autonomic Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Bronchodilator Agents |