Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium, Administered Add-on Therapy
This study has been completed.
Sponsor:
Cosmo Technologies Ltd
Information provided by:
Cosmo Technologies Ltd
ClinicalTrials.gov Identifier:
NCT00867438
First received: March 20, 2009
Last updated: March 24, 2009
Last verified: March 2009
Tracking Information | |||||
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First Received Date ICMJE | March 20, 2009 | ||||
Last Updated Date | March 24, 2009 | ||||
Start Date ICMJE | January 2007 | ||||
Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The number of patients achieving clinical remission (CAI <4). [ 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 NCT00867438 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Endoscopic Index, Histologic Score of mucosal bioptic specimens, AEs, laboratory parameters, vital signs. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium, Administered Add-on Therapy | ||||
Official Title ICMJE | Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium (CB-01-05-MMX™), Administered as Add-on Therapy to Oral Mesalazine or Other 5-ASA Derivatives, in Patients With Active, Left-Sided, Mild to Moderate Ulcerative Colitis. A Multicentre Randomized, Double-Blind, Comparative Study Versus Placebo. | ||||
Brief Summary | The objective of this study is to evaluate the efficacy and the tolerability of oral parnaparin sodium (210mg), administered in extended-release tablets identified as CB-01-05-MMX™. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Ulcerative Colitis | ||||
Intervention ICMJE | Procedure: Sigmoidoscopy | ||||
Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 133 | ||||
Completion Date | November 2007 | ||||
Primary Completion Date | November 2007 (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 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00867438 | ||||
Other Study ID Numbers ICMJE | CB-01-05/04 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Cosmo Technologies Ltd | ||||
Study Sponsor ICMJE | Cosmo Technologies Ltd | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Cosmo Technologies Ltd | ||||
Verification Date | March 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |