Tracking Information
Start Date ICMJE | June 2008 |
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Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: May 15, 2008) | To evaluate the clinical efficacy and safety of budesonide-MMX™ (CB-01-02) 6 mg and 9 mg oral tablets in patients with active mild or moderate ulcerative colitis, when administered for 8 weeks, and compared to placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00679380 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 15, 2008) | Efficacy & safety of oral budesonide-MMX 6 mg and 9 mg compared to 3 times daily Asacol®. To evaluate the improvement in rectal bleeding,endoscopic, histological, bio humoral parameters. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Randomized Placebo Controlled Trial of Budesonide-MMX™ 6 mg and 9 mg in Patients With Ulcerative Colitis |
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Official Title ICMJE | Efficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC |
Brief Summary | This will be a multicentre, randomised, 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 Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period. After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Ulcerative Colitis |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 492 | ||||
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Estimated Completion Date | August 2009 | ||||
Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Australia, Belgium, Estonia, France, Italy, Latvia, Lithuania, Poland, Romania, Russian Federation, Slovakia, Sweden, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00679380 | ||||
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Responsible Party | Desirée Richold/ Clinical Project Manager, ICON Clinical Research | ||||
Study ID Numbers ICMJE | CB-01-02/02 | ||||
Study Sponsor ICMJE | Cosmo Technologies Ltd | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Cosmo Technologies Ltd | ||||
Verification Date | January 2009 |